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Regulatory Affairs Consulting Services: Pharma & Medical Device Registration

Let us help you gain approval for medical device registration and new pharmaceutical products and ensure that authorisation is preserved by your company and on the pharmaceuticals market!

What is Regulatory Affairs in Singapore?

Regulatory affairs oversee the procedures involved in gaining approval and maintaining adherence to local regulations. Whether it is a pharmaceutical product or medical device registration and the launch of a new supplement, they work to protect public health and ensure safety by subjecting medical and pharmaceutical companies to strict laws.

Regulatory Affairs Consulting Services: Pharma & Medical Device Registration

Navigating the regulatory process of medical products can be taxing, TRC can support you by providing regulatory consulting services, identifying gaps of your present dossier, performing regulatory intelligence activities and supporting pre-market consultation so as to eliminate any potential regulatory hurdles with non-compliance issues.

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Regulatory Representative Office

TRC understands that clients will require a single point of contact for ASEAN operation work and hence we are able to support the following services:

  • Market research based on therapeutic areas
  • Project management
  • Mediation services between Distributors and Principals
  • Local representative office services (non-accounts related)

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Quality management system graphic for pharma regulatory services

Quality Management in Regulatory Affairs

TRC specialises in pharma regulatory services, supporting clients with their medical device registration. We prioritise the efficacy and safety of each pharmaceutical product, ensuring compliance with Good Distribution Practices (GDP), ISO 13485, and ISO 9001 requirements. Our expertise streamlines the process, making it easier for your products to gain regulatory approval and meet the highest industry standards.

  • QMS documentation set-up
  • Internal audit

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Regulatory Affairs

TRC supports clients in managing their day to day regulatory work as per services offered below:

  • Pre-licensing activities such as dossier submission to local health authority, review of dossier to align to local regulatory requirements, liasion support for regulatory submission cycle.
  • Post-licensing activities such as renewal, variations, change notifications, market recall activities.
  • Regulatory support in daily operations work ( link to regulatory subscription plan)
  • Licence holding
  • Consulting for regulatory advices
  • Artwork and marketing materials review

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Why Choose Our Regulatory Consulting Services

• Expertise

Benefit from our years of experience in regulatory affairs across various industries, including pharmaceuticals, medical devices, biotechnology, and more. 

• Hassle-Free Process

Our regulatory consulting services meticulously review and strategise every aspect of your regulatory affairs to ensure a smooth sailing approval process. 

• Speedy Approach

Time is of the essence, so we work to help you bring your products to the market faster without compromising on quality or compliance. 

• Comprehensive Support

From initial assessments to ongoing compliance maintenance, our consulting services cover the entire spectrum of regulatory affairs for comprehensive support at every stage.

FAQs about Pharma & Medical Device Registration

Regulatory affairs involves navigating the complex regulatory requirements and processes necessary for the approval, marketing, and compliance of products or services. It's crucial for ensuring that your business operates within legal boundaries, maintains product safety and efficacy, and successfully brings products to market.

Yes, our team has extensive experience in assisting companies with pharmaceutical products and medical device registration in Singapore. We provide comprehensive support throughout the registration process to ensure compliance with regulatory requirements and facilitate timely approval.

The timeframe for obtaining regulatory approval varies depending on factors such as the type of product, complexity of the regulatory process, and the completeness of the submission. However, with the right assistance, such as a regulatory consulting service, you can expedite the approval process.

The pharmaceutical registration process in Singapore involves submission of an application to the Health Sciences Authority (HSA), including comprehensive data on product quality, safety, and efficacy.

Yes, Singapore has strict regulations governing the importation of pharmaceuticals and medical devices. Importers must obtain appropriate licences and permits from regulatory authorities.

Hand picking pharmaceutical product for regulatory consulting in pharma
If you have any specific regulatory questions pertaining to entering the Singapore market or require assistance with pharma regulatory services and medical product registration, feel free to reach out. Your success in the pharmaceutical industry starts with us!

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