Regulatory Support

From classification to compliance - regulatory execution without the guesswork.

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Overview

Built for precision and continuity, our regulatory services turn complexity into clarity. Whether you're entering new markets or strengthening compliance, we enable faster approvals, stronger control, and long-term regulatory confidence across every stage of your journey.

Regulatory Strategy & Intelligence

Product Classification & Regulatory Pathway Assessment

Risk Classification ( MD)

Regulatory Roadmap (Single & Multi-Market)

Global Regulatory Mapping (Label, Ingredient, Claims Restrictions)

Innovation Launch Advisory with Regulatory Milestones

Technical Documentation Review

Ingredient and Formulation Compliance Review

Claims Substantiation & Acceptability Review

Instructions for Use (IFU) & Packaging Review (MD)

CMC Documentation review

Regulatory Submissions

CTD/eCTD Dossier Compilation

Technical File Preparation (EU MDR/IVDR – Devices & IVDs)

Clinical Evaluation Report (CER)

Performance Evaluation Report (PER)

ASEAN Cosmetic Notification Dossier

PIF Compilation

CE Marking Submission Support

US FDA 510(k), NDI, Facility or Device Registration

Renewal, Variation, and Change Filings

Country-Specific Submission File Localisation & Translation

Import License Filing (Including MAH Representation)

Product License Transfers

Advertising/ Promotional Compliance permits

Quality & Audit Complaince

GxP Audit support (USFDA, EU GMP, TGA)

Halal certifications (Facility & Product)

Document Control System Setup (QMS)

Regulatory SOP Development (Internal Teams or Partners)

Internal Regulatory Team Training (Workshops, Templates, Systems)

Innovation Capability Building (for Startups or Launch Teams)

Ready to Build Your Regulatory Advantage?

Let’s accelerate your compliant innovation, market entry success, and global expansion together.

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