Regulatory Affairs Consulting

TRC provides regulatory affairs support for companies preparing for submission, addressing deficiencies, or requiring structured regulatory strategy across pharmaceuticals, medical devices, cosmetics, and health supplements.

The objective is to ensure submissions are aligned with CTD formats (ASEAN, ICH, or eCTD) and local regulatory expectations, reducing the risk of delays or deficiencies.

When You Need This

Your product is being prepared for first-time registration
Your dossier is not aligned with CTD formats (ASEAN, ICH, or eCTD) or local regulatory expectations
You require a structured gap analysis prior to submission
You have received queries or deficiencies from the authority
Your internal team lacks regulatory expertise or bandwidth

Regulatory Strategy & Planning

Classification and regulatory pathway assessment
Submission strategy aligned with local authority requirements

Dossier Preparation & Review

Preparation and restructuring of dossiers (e.g. CTD format)
Technical review of Modules 2–5
Assessment of eCTD readiness (structure, format, and technical compliance)
Identification of critical gaps and deficiencies

Gap Analysis

Pre-submission assessment against regulatory expectations
Identification of risks impacting approval

Deficiency Response

Drafting and structuring responses to authority queries
Alignment with submitted dossier and regulatory expectations

Submission Management

Preparation and compilation of submission packages
Execution of submissions to regulatory authorities
Management of submission process and timelines

Approach

Each engagement is approached with a structured review of available data, identification of regulatory risks, and practical recommendations aligned with submission expectations.

Contact TRC

Contact TRC to discuss your product and regulatory requirements.

Regulatory Affairs