Brazil pharmaceutical companies offer a diverse and innovative portfolio of products. However, due to geographical distance, most companies focus on developing their market within Brazil and the U.S. There are many compelling reasons for Brazilian companies to consider expanding into Singapore and other ASEAN countries, where they can leverage strategic regulatory advantages and market opportunities that support efficient entry and growth.

Regulatory Synergies: Singapore and Brazil

One of the key regulatory advantages for Brazilian companies looking to enter the ASEAN market is that Brazil’s health regulatory authority, ANVISA, is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Many ASEAN countries, including Singapore, require PIC/S GMP compliance, allowing Brazilian companies to bypass additional inspections during the registration process. This waiver can significantly reduce lead times in regulatory approval, giving Brazilian companies a quicker route to market.

Climate Compatibility: Shared Zone IVb Stability Requirements

A unique advantage Brazil holds is its geographic location in Zone IVb, which aligns with ASEAN’s required climatic stability conditions for pharmaceutical products. This means that Brazilian companies can use existing stability studies, avoiding the need for additional testing specific to the ASEAN region. This shared climatic zone can result in considerable cost savings on stability studies and compliance, giving Brazilian products a competitive edge in terms of time and expense.

Comparing Regulatory Processes: Brazil vs. Singapore for Generic and New Drug Registration

While there are similarities, it’s essential for Brazilian companies to understand the regulatory differences between Brazil and Singapore, especially regarding generic and new drug registration. Below are key considerations that companies should factor into their ASEAN market expansion strategy.

1. Registration Pathways

In both Brazil and Singapore, the registration pathway differs significantly for new drugs versus generics. For instance:

New Drugs: In Singapore, Health Sciences Authority (HSA) offers a structured pathway for innovative and new drugs, which may include priority review  if the drug is deemed essential and lacks alternatives. In contrast, ANVISA in Brazil also has a pathway for new drugs, though companies may face longer timelines due to a multi-stage evaluation process.

Generics: The process for registering generics tends to be faster in both Brazil and Singapore, but while ANVISA requires proof of bioequivalence and local testing, HSA may accept certain international data, reducing redundancy and potentially expediting registration for companies with existing global dossiers.

2. Evaluation Timelines

Evaluation timelines vary widely:

In Brazil, ANVISA’s timelines can range from six months to two years depending on factors such as product type and completeness of the initial submission. Backlogs can also affect timelines, particularly for new drug applications.

HSA is known for shorter timelines, often ranging from nine to eighteen months for both new drugs and generics, especially for applications that meet international standards and are well-documented. Singapore also offers prioritized processing for essential medications, which may benefit companies with innovative therapies.

3. Documentary Requirements: Common Technical Document (CTD)

Both Singapore and Brazil use the CTD format, but specific requirements within the document vary, particularly for Modules 2-5:

Module 2 (Quality Summary): In Singapore,  HSA requires a comprehensive QoS which may differ from ANVISA’s requirements.

Modules 3 to 5: For new drugs, Brazil and Singapore both demand comprehensive preclinical and clinical data, but Singapore may accept foreign clinical trial data if it’s from recognized health authorities, whereas ANVISA may require supplementary data to align with Brazilian standards.

4. Stability and Climatic Zone Requirements

Given the shared Zone IVb classification between Brazil and ASEAN countries, Brazilian companies can often use existing stability studies for Singapore, eliminating the need for additional stability testing. This alignment is particularly advantageous for generics, as it simplifies compliance with local stability requirements in Singapore.

5. Labeling and Language Requirements

Singapore mandates labeling in English, and specific products may require simplified language for consumer understanding. Brazil similarly requires Portuguese labeling for domestic sales.

 

Making Expansion Decisions Easier: A Simple Regulatory Checklist

For Brazilian companies considering expansion into the ASEAN market, the following checklist can support a preliminary regulatory assessment, helping to identify both potential hurdles and advantages:

• Registration Pathway: Assess whether the registration pathway aligns with your product type, as requirements may differ significantly between new drugs and generics.
• Evaluation Timeline: Consider the estimated evaluation timeline for product approval, which can vary based on the specific ASEAN regulatory authority’s processes and the complexity of the product type.
• Technical Dossier Requirements (M2-M5): Review the dossier sections required for submission in ASEAN, particularly Modules 2 to 5 of the Common Technical Document (CTD). This assessment should take into account if the product is a new drug or a generic, as requirements may differ.
• Labeling Requirements: Ensure compliance with ASEAN-specific labeling requirements, which often include language adaptations and specific formatting to meet local standards.

By considering these key points, companies can conduct initial regulatory intelligence to streamline the expansion process. If your company is ready to enter the ASEAN market, The Reg Consultants (TRC) is available to provide expert regulatory support, helping you navigate these requirements with ease.

Feel free to check out other relevant articles:

https://theregconsultants.com/overcoming-the-challenges-of-registration-of-a-generic-drug-in-singapore/

https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/

https://theregconsultants.com/why-is-regulatory-intelligence-exercise-crucial-for-pharma-companies-looking-to-expand-into-new-territories/

https://theregconsultants.com/5-self-check-questions-for-pharma-market-access-in-singapore/

 

 

In recent times, we’ve received numerous inquiries about the possibility of rebranding complementary health and cosmetic products in Singapore, particularly due to geopolitical factors. Many companies are looking to facilitate export to their home countries, and understanding how to rebrand products as “Made in Singapore” can be a strategic advantage. In this article, we’ll explore what constitutes a product as “Made in Singapore,” the  pathway  to achieve this , and the certifications available from Singapore Customs , Singapore Manufacturing Federation, as well as the Singapore International Chamber of Commerce, that can facilitate export.

What is Considered a “Made in Singapore” Product?

A “Made in Singapore” product refers to goods that are substantially manufactured or processed within Singapore, in line with regulatory criteria established by local authorities. To earn this designation, a significant portion of the production costs—including labor and materials—must be incurred locally, ensuring considerable local value addition. Furthermore, products must comply with Singapore’s safety, health, and environmental standards to meet quality expectations.

It’s essential to note that if a product is manufactured outside of Singapore and only undergoes labeling or assembly here, it may be labeled as “Packed in Singapore” or “Secondary assembled by ABC Pte Ltd in Singapore.” However, it cannot be marketed as “Made in Singapore,” as this designation necessitates significant manufacturing or processing within the country.

Importance of Free Sale Certificate (FSC) and Certificate of Origin (COO)

When exporting goods, obtaining a Free Sale Certificate (FSC) and a Certificate of Origin (COO) can significantly streamline the process and enhance market acceptance in your destination country.

• Free Sale Certificate (FSC): Issued by Singapore Customs, the FSC confirms that the products are sold locally in Singapore and are compliant with local regulations. It serves as a testament to the product’s quality and safety, making it easier for foreign authorities to accept the product without extensive scrutiny.
• Certificate of Origin (COO): This document attests to the origin of the goods and is essential for international trade. Many countries require proof of origin to determine applicable tariffs and compliance with trade agreements. There are two types of COOs:
  • Ordinary COO (Non-Preferential): Identifies the origin of the good but does not allow overseas buyers to claim preferential tariff treatment, as it is not issued under any Free Trade Agreement.
  • Preferential COO: Enables your buyer to benefit from lower or no customs duty when exporting under a Free Trade Agreement or Schemes of Preferences.

Steps to Brand Your Complementary Health Products or Cosmetics as “Made in Singapore”

1. Set Up a Manufacturing Facility: Establish a manufacturing facility that adheres to Good Manufacturing Practice (GMP) requirements to produce your product, or partner with a licensed contract manufacturing facility that specializes in complementary health products. Ensure that your facility is registered with relevant authorities to facilitate inspections and audits.
2. Ensure Regulatory Compliance: Comply with the relevant regulatory controls for your type of health product. Prepare comprehensive documentation to establish the quality, safety, and efficacy of your product. This documentation should include:
   • Product specifications
   • Safety data sheets
   • Clinical studies (if applicable)
   • Quality assurance protocols

Seek the appropriate approvals before marketing and distributing it locally. This may involve obtaining licenses to import and distribute if necessary.

3. Obtain Necessary Certifications: Once you receive approval from the regulatory authority, you can apply for a Free Sale Certificate from Singapore Customs or a Certificate of Origin from the Singapore Manufacturing Federation and the Singapore International Chamber of Commerce to facilitate exportation, depending on the domestic procedures of your destination country.
   • Free Sale Certificate: To apply for the FSC, submit your application along with supporting documents that demonstrate your product’s compliance with local regulations. The certificate will detail the product’s description, registration numbers, and the local regulatory authority’s confirmation.
   • Certificate of Origin: To obtain a COO, you will need to provide documentation that supports the origin of your goods. This may include:
     • Invoices
     • Shipping documents
     • Manufacturing process details

COs are issued by the Singapore International Chamber of Commerce and the Singapore Manufacturing Federation. Ensure that you are familiar with the requirements of the importing country to facilitate a smooth export process.

For further information, please refer to the following resources:

• Certificate of Origin
• Singapore Customs FAQs

We hope this information proves useful to you. Be sure to check out our other related blogs that may interest you:

• 3 Facts to Know When Importing Cosmetics into Singapore
• Addressing Regulatory Challenges in the Cosmetics and Personal Care Industry in Singapore
• Navigating Nutraceutical Regulations Within the ASEAN Region
• Key Things to Note When Importing Health Supplements into Singapore

 

Previously, drug substance manufacturers submitting applications for new drugs, generic drugs, or minor variations involving the introduction or change of a drug substance (DS) manufacturer were not required to provide GMP evidence. However, starting from October 1st, it is essential to note that GMP compliance evidence will be mandatory for these submissions in Singapore. This regulatory change aligns the quality requirements for drug substance manufacturers with those for drug product manufacturers, ensuring a consistent standard of quality across the industry.

Required Evidence for GMP Compliance

To comply with the updated regulations, drug substance manufacturers must submit the following acceptable forms of GMP compliance evidence:

1. GMP Certificate: Issued by PIC/S (Pharmaceutical Inspection Co-operation Scheme) member authorities for the specific drug substance.
2. GMP Inspection Report: This report must detail the GMP inspection, including the drug substance of interest, along with a close-out letter from PIC/S authorities that do not issue certificates.
3. API Registration Certificate: This certificate confirms that the Active Pharmaceutical Ingredient (API) is listed on EudraGMDP (European Database on Good Manufacturing Practices).
4. Certificate of a Pharmaceutical Product (CPP): This must be issued by the US FDA for the API.
5. Manufacturing License: A license from a PIC/S authority covering the drug substance of interest.

Implications of the New Requirement

As these new regulations take effect, there will be several implications for products already registered in Singapore or those planning to submit applications:

• For new drug and new generic drug applications scheduled for submission in Q3-Q4, manufacturers will need to reassess their compliance with the new requirements.
• Existing products that involve a change of manufacturing site will require a reassessment of the supplier’s conformity to the GMP standards mandated in Singapore, which may impact the overall product lifecycle.

Important points to note:

• Products that were approved or submitted before October 1st will not be affected by this new requirement.
• DS manufacturer who has a valid CEP issued for their DS complying to the monograph of European Pharmacopeia , the submission of the GMP evidence is optional.

Ensuring GMP compliance is more than just a regulatory obligation; it represents a commitment to quality and patient safety. By preparing the necessary documentation and adhering to GMP standards, manufacturers can streamline their approval processes and enhance their credibility within the industry.

If you require assistance in evaluating your dossier prior to submission or have any questions regarding GMP compliance, please don’t hesitate to reach out. We are here to help you navigate these requirements effectively.

 

Entering a new market like Singapore can indeed be a strategic move for Chinese pharmaceutical companies expanding into Southeast Asia. Today TRC would like to highlight 6 key areas from a regulatory perspective:

1. Quality of the CMC documents- Drug Substance

 2. Quality of the CMC documents- Drug Product

5.Language Barrier-  Dossier written in  simplified Mandarin should be translated and verified in a way that the content reflects what is written in the original language and official documentation such as Proof of GMP, approval letters should be authenticated by the foreign embassy or consulate of the country of origin. 

6. Marketing Authorization Requirements–In Singapore, only a local registered entity can hold the marketing authorization for pharmaceutical products. This means that companies seeking to market their products in Singapore must either establish their own legal entity in Singapore or engage a consultant who operates locally.

The MAH is responsible for ensuring compliance with regulatory requirements throughout the lifecycle of the product. This includes responsibilities such as product registration, pharmacovigilance, labeling and advertising compliance, and maintaining a quality management system.

To learn more about the responsibilities of a MAH, please visit: https://theregconsultants.com/responsibilities-of-a-marketing-authorization-holder-mah/

With that we have concluded key areas to evaluate prior to entering the Singapore market, if you need help and support to evaluate your dossier for registration in Singapore, please feel free to get in touch: https://theregconsultants.com/contact-us/

 

 

 

All overseas manufacturing sites are subjected to GMP conformity assessment by the local authority. GMP conformity assessment is in support a therapeutic product registration. Only local registered entity in Singapore can support the GMP conformity assessment application. The cost and timeline is dependent on the pathway in accordance to the pathway.

 

What is GMP conformity assessment?
GMP conformity assessment or Overseas Audit Program Assessment refers to evaluation of a new overseas manufacturing site in compliance to established GMP guidelines. Singapore being part of PIC/S scheme member countries adopt the PIC/s standard for Good Manufacturing Practices for Medicinal Products.

 

1st pathway : GMP Documentary Evidence Verification (DEVA)
This pathway is only feasible for proof of GMP compliance that are issued by PIC/S member authority. Acceptable proof of GMP compliance includes manufacturing license, GMP certificate and CPP issued in WHO format.
Applicant would need to ensure that the submission of the proof of GMP compliance is in English language, original scanned colour copy and indicates the basic information of the manufacturing site including name and address, dosage form, authorized activity and GMP standards of which the manufacturer complies with.
The fee is SGD$630 per manufacturing site per dosage form. There is no specific timeline involved as this is evaluated in conjunction with the submission of a product registration. Once the site is registered, there will not be a need to go through a similar conformity assessment for a similar dosage form.

 

2nd pathway Overseas On-site Audit 
Manufacturers would be subjected to this pathway due to the following conditions such as unavailability of acceptable GMP evidence, inadequate GMP evidence to demonstrate compliance, regulatory concern regarding GMP compliance of manufacture or product alert related to product defect or recall associated with the site concerned.
For this pathway, application would need to prepare a Quality System Dossier in accordance to Preparation of a Quality System Dossier (GUIDE-MQA-019) with a list of supporting documents to the authority for evaluation. Once the application is accepted for evaluation, an overseas inspection will take place based on the schedule of inspectors and availability of the manufacturing site that is to be audited.

 

The fees are presented below:
QSD evaluation- $4,770
On site audit located in ASEAN country- $18,400
On site audit located in ASEAN- $20,400
On-site audit located outside of Asia- $24,400

 

Post inspection, the authority will issue a letter to summarize the inspection including any potential observations or deficiencies that are required to be addressed. Applicant will be given about a month time to provide CAPA.
Upon successful close out of the post inspection findings, the applicant will be informed of the outcome.

 

We hope the above information is supportive for your product registration in Singapore If you need help to evaluate your GMP documents , please get in touch or if not feel free to share with your peers.

 

Useful references:
1. https://www.hsa.gov.sg/therapeutic-products/register/gmp-conformity-assessment
2. PIC/S Guide to GMP for Medicinal Products.

 

The ASEAN Joint Assessment Procedure is a procedure in which the same marketing authorization application is simultaneously submitted to all participating ASEAN National Medicines Regulatory Authorities (NRAs).

ASEAN National Medicines Regulatory Authorities (NRAs) includes:

• Health Sciences Authority (HSA)- Singapore
• National Pharmaceutical Regulatory Agency (NPRA)- Malaysia
• Thai Food and Drug Administration (Thai FDA)
• Food and Drug Administration (Philippines FDA)
• Badan Pengawas Obat dan Makanan (BPOM),Indonesia
• Drug Administration of Vietnam (DAV)
• Ministry of Health, Brunei (MoH, Brunei)
• Department of Drugs and Food (DDF), Cambodia
• Food and Drug Administration Myanmar
• Food and Drug Department (FFD) , Laos

The join assessment procedure is initiated with minimum of 3 NRAs.

At the moment , it covers only :

1. a) medicines for treatment of priority diseases in ASEAN region such as but not limited to: treatment for specific cancers such as breast , lung, Hepatitis C, treatment of AIDS/HIV, Tuberculosis, Treatment-Resistant Depression.
2. b) products already approved by a reference National Regulatory Authority(NRA) ,prequalified by WHO-PQP, or assessed through special regulatory pathways such as EU Article 58 or US-FDA tentative approval;
3. c) products manufactured in a PIC/S-GMP compliant site

Process in brief

1. Participating National Regulatory Authority(NRA) publish on their website in the form of a Notice : Notices of Invitation to Express Interest.
2. Applicant can submit their interest by filling up the appropriate application form to the authority.
3. Lead NRA seeks concurrence of participating NRAs for accepting Expression of Interest
4. Lead NRA requests applicant to submit required documentation to participating NRAs.
5. Assessment work is then carried out together by all participating NRAs and a joint assessment report is prepared
6. At the end of the process, the final decision on the application is then taken, within established time lines, by each individual NRA through their normal decision-making process based on the joint report and, where applicable, nationally-relevant considerations.

Applications must comply to the following:

1. the technical application dossier must include the same technical information as that submitted to reference NRA or WHO-PQP;
2. b) the technical part of the dossier in ACTD or ICH-CTD format shall be provided in electronic form to be uploaded to a dedicated, secure web site set up by WHO; only participating NRAs will be able to access and download the dossiers;
3. c) administrative part of dossier specific to each participating NRA requirements will be submitted directly to each participating authority;
4. d) fees as required by each participating NRA will be paid according to normal national procedures.

Processing timeline: 180  working days for assessment procedure

If you have a product that may fall into the therapeutic area mentioned  and need support for submission, please feel free to get in touch with TRC.

Useful references:

1. List of Priority Products
2. Processing timelines
3. ASEAN-JA-Procedure-for-Pharmaceutical-Products-Information-for-Applicants

 

It has come to the end of the year where budgeting and planning are in full force for 2024.  In regulatory, we do it via the RPA way which stands for Review, Plan and Act .

TRC shall share a short summary on what RPA means :

Review

1. Start off with product annual review to check for gaps and alignment with global database.
2. Align the schedule and activities with headquarters for the upcoming year so that you can roll out the relevant schedule and communication plan.
3. Prepare communication plan or schedule of upcoming variations and new product registrations for each specific market and inform respective partners of the timeline and what to expect. This is an important exercise to also get input on any new regulatory requirements that might be happening within the local market.
4. Identify key areas to work on internally as well as with respective local partners.

Plan

1. Align the regulatory launch plan with commercial launch plan and obtain consensus on priorities of the variations and new product launches.
2. Budget the amount required for respective expenditures to partners, authorities, operating expenses ,travel expenses, any pass-through costs involving translation work if applicable .
3. Plan for face to face meeting and annual audit with respective partners as part of due diligence and to maintain the good rapport between yourself and them if applicable.
4. Ensure that consensus on activities and budget are obtained and accurate till date.

Act

1. Hold meeting with internal and external stakeholders to confirm the plan.
2. Adjust the plan and schedule accordingly after meeting to ensure alignment to concerned parties’ inputs.
3. Prepare the respective packages for each product that is specific to each market.
4. Execute the plan accordingly to schedule and be ready to support when issues arise.

We hope the above short sharing is interesting for your read. If you need support for your regulatory activities in the coming year in Singapore, feel free to get in touch.

 

The next step after performing a regulatory intelligence exercise would be followed by an arrangement for a consultation with the regulatory authority. This is common especially for IND application and NDA application in which there may be concerns regarding the documentation requirements or even addressing any critical CMC, pre-clinical and clinical study related questions. Today TRC shall share based on observation from the past on what’s the Dos and Don’ts during a formal regulatory consultation meeting in tabular format:

Note that this is just based on TRC’s suggestion of best practice and we do not advocate or represent any voices.

Dos	Don’ts
Present your best self by dressing appropriately and finding a quiet place to participate in the meeting.  Switch on the camera during video call meeting.	Do not appear as an unkempt look  or even join the meeting in a noisy place to create unpleasant “white noise” during the meeting. If you are unable to switch on the camera during the call, remember to inform during the meeting.
Ask questions that are within the meeting agenda provided.	Do not ask questions for the sake of asking questions if they are not necessary.   In a regulatory meeting, there will be different department personnel joining in. But it would be best to limit those who are  executing the work and have an influential decision on how to move the application forward to avoid any unnecessary question or awkward silence to have a need to ask question.
If the explanation is not clear or specific enough even though the time is running out, ask politely whether you could clear out this important issue so as not to leave it hanging.	Do not keep pressuring the regulators to double confirm the answers that they are providing. A written response would be provided at the end of the meeting. If there is anything that is not clear, you can write back again once the email is received.
Be respectful and transparent about the application that you are intending to submit. Give an overview of the application preparation and the objectives of what you intend to achieve within the meeting.	Do not have more than “one” voice interrupting the flow and “ over talking” about the application that you are intending to submit during the meeting to avoid any confusion or misunderstanding which will not provide you with the appropriate response that you are looking for.
Follow a systematic approach to start off the meeting which is by being punctual, following the agenda of the meeting strictly and avoid any over discussion so  as to not waste any precious time allocated.	Do not trail off the main questions during discussion and allow the regulator to provide the guidance and ask the next question in sequence unless the question that you have in mind is extremely critical or related to the response that you are hearing.
At the end of the meeting, it’s good to pre-empt or suggest a follow up “informal” call by a designated representative should there be any concern that is not well understood from the formal responses provided.	Consolidate all the queries that you have in mind after reviewing the responses provided by the regulators and avoid  bombarding them with calls from different people. They are not your answering machines.

 

If you think that the above article is useful for you , feel free to share it with your peers and we are also looking forward to hearing some of your experience during consultation meeting. If you require assistance to arrange and support any formal meeting with the local authority, get in touch!

 

Part of our routine activity in regulatory affairs is to stay in touch with the latest updates and happenings with our local authority so that we can interpret the new changes, assess the impact it has on our existing product licenses and implement a strategic plan to incorporate the changes. Today TRC would like to share the key steps in a typical internal regulatory assessment of new regulations changes:

1. Understand the regulations thoroughly

Ensure that you obtain  the latest draft or correct version of the new regulations and read the context in dept. Compare it with the current regulations and make notes on the differences that could be important for you to bridge the gaps.

When the draft guidelines are issued for consultation,  ask all the questions that you have in mind to align your own understanding and to clear any doubts regarding the new changes.

If there are training sessions conducted by the authority prior to the implementation, it will be good to participate so as to refresh your memory and to enhance the understanding and learn about any new concerns during the Q and A session from other participants.

2. Perform an internal assessment

Determine the BU (business unit)  and product line that will be affected by the new regulations. Obtain the status of the marketing authorization and a brief understanding of the  commercial status of the product in the territory involved.  

Perform a gap analysis and document the gaps in  order to bridge and incorporate the new change. This should be documented as concise and to the critical point as possible. Share the internal assessment document  with the appropriate business unit to obtain feedback so that you can align the findings that you have identified during the gap analysis.

3. Determine the steps to incorporate the change

Using the internal assessment as a guideline, prioritize changes in terms of criticality,  the commercial impact on the product line and the resources available to support the implementation. Draw up a plan to  strategize the implementation and align with local stakeholders and business unit on the requirements and timeline.

Monitor the process of implementation and review post implementation for areas of improvement and effectiveness as well as to capture any areas that were missed out during the initial phase of implementation.

Although the above steps are simple , there may be a risk of miscommunication and  lack of internal resources when simultaneous of such regulatory changes are implemented, it could be useful to consider an additional experienced local support . If you think that TRC could be of help to you , please get in touch or learn more about how TRC subscription plan can facilitate the process.

 

As a regulatory service provider aka consultant, each regulatory consultant has their own unique way of execution of regulatory task especially for regulatory submission.  However it would not differ too much from what we are going to share with you.

TRC would like to share with potential prospects of how we usually manage regulatory submission.  Please refer to the steps below:

1. To initiate the regulatory submission flow, TRC would request Client to provide a secured link for us to access the dossier.
2. When dossier is downloaded , TRC would first begin to verify that all sections of the CTD is provided and also verify the file size . For file size exceeding the uploading size onto submission platform, a request would be sent to the Client to split the pdf into smaller size and re-send it to us.
3. TRC would execute minor formatting such as renaming of modules if not named appropriately as an example. However, TRC do not do any publishing or formatting of CTD to e-CTD.
4. A gap analysis exercise is conducted to identify the points to be addressed prior to submission accordance to classification of the product and evaluation pathway. The gap analysis report will be sent to the prospect to work on the gaps for our review. This would usually take about minimum of 3 round and not exceeding 5 rounds.
5. Once the gaps are addressed, we would proceed to perform online submission including the application form filling and uploading of documents.
6. Once submission is completed, TRC would furnish the entire set of dossier and a copy of the submission form to the prospect for their reference. TRC also perform our due diligence to keep track of the timelines to receive 1^st set of screening queries and between stages throughout the evaluation process to ensure that the submission is on track.
7. During the evaluation process, TRC lends their support by facilitating and reviewing the responses provided by the prospect to answer to the queries raised by the evaluator. Similarly, TRC would take the initiative to clear any doubts with regards to the query letter raised to support the prospect to provide the required responses. This is to ensure that each round of evaluation process would be well answered and to avoid duplication of questions from both ends.
8. Once approval is received via email, TRC will notify the prospect and remind the prospect to take note of the post-licensing condition imposed in the notification email.

We hope that above  has been useful for you if you are contemplating to engage us to support your regulatory submission in Singapore. Do reach out or explore TRC’s new and articles to navigate through article that are useful to you.