enquiries@theregconsultants.com
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What is Regulatory Affairs in Singapore?
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)
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
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
Why Choose Our Regulatory Consulting Services
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.
