About Us

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!

Regulatory Affairs Consulting Services: Pharma & Medical Device Registration

Navigating the entire process of pharma regulatory services in Singapore can be quite challenging and draining due to its complex nature. However, with the expertise of TRC in pharma regulatory services, we can help you simplify the entire process of seeking approval for your medical device registration and other upcoming pharmaceutical products. Our role is to help you get through without any hassle, from the preclinical testing and gaining approval to entering the market.

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


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 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)


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!

We use cookies to ensure you get the best experience on our website.