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 System (QMS)
TRC supports client to manage their QMS setup and conduct internal audit to ensure compliance to Good Distribution Practices (GDP) and ISO 13485, ISO 9001 requirements as per services listed below:
- QMS documentation set-up
- Internal audit
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)