enquiries@theregconsultants.com
0
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
