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Regulatory Affairs
TRC provides strategic regulatory affairs support tailored to client needs across pharmaceuticals, medical devices, cosmetics, health supplements and related products. Our approach focuses on helping clients navigate regulatory pathways, satisfy authority requirements and maintain compliance throughout the product lifecycle.
Our advisory support typically encompasses the following areas based on client needs and regulatory context:
Pre-licensing and Market Entry Support:
- Regulatory pathway assessment and submission strategy
- Review and alignment of technical dossiers and documentation with local regulatory requirements
- Coordination and liaison with relevant regulatory authorities throughout the submission and review cycle
Post-licensing and Compliance Support:
- Renewal and licence maintenance planning
- Management of variations and change notifications
- Advisory support for regulatory actions, including market recall coordination where required
Operational and Ongoing Regulatory Support:
- Day-to-day regulatory advisory for lean internal teams
- Regulatory consulting on specific issues or questions
- Review and advisory support for artwork and marketing materials to ensure regulatory alignment
Licence Holding and Representation:
Where appropriate and permitted by local regulations, TRC can advise on licence holding considerations and the role of regulatory representation within the regulatory framework.
Regulatory Representative & Regional Coordination Support
TRC supports clients requiring a central regulatory point of contact for ASEAN-related activities, particularly for companies operating with lean local teams or without an established regional regulatory presence.
This support is provided strictly within a non-commercial, non-financial and advisory capacity, and may include:
Regional Regulatory Coordination:
- Acting as a regulatory coordination point for ASEAN-related regulatory communications
- Supporting alignment across markets on regulatory timelines, submissions and post-approval activities
Project and Stakeholder Management:
- Regulatory project coordination across multiple stakeholders, including distributors and local partners
- Facilitation and mediation on regulatory matters between principals and local distributors where required
Regulatory Intelligence & Market Assessment:
- High-level regulatory landscape assessment based on therapeutic area and product category
- Identification of regulatory considerations impacting market entry or lifecycle planning
(This does not include commercial market research or sales analysis.)
Local Regulatory Representation (Non-Financial):
- Support as a regulatory representative point of contact where permitted by local regulations
- Excludes accounting, invoicing, sales, or commercial representation activities
Scope and responsibilities are defined on a case-by-case basis, subject to local regulatory requirements and client needs.
