Pharmaceutical Regulatory Affairs Services
Regulatory Affairs consultancy services for the medical and pharmaceutical industries.
Intertek’s Pharmaceuticals & Healthcare Regulatory Affairs team is a niche scientific and regulatory consulting group. We guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, combination products, and other healthcare products for all stages of development.
We are a team of experienced regulatory professionals in the US and Canadian regulatory environments who advise and provide regulatory support for products in all stages of development (preclinical to post-market). We collaborate with companies to bring products to the market in the most efficient and cost-effective manner, within an evolving and increasingly challenging regulatory environment.
Pharmaceutical Regulatory Affairs Services:
Clinical Trials
Marketing Applications
Product Lifecycle Management
eCTD Publishing, ESG & Technical Support
Submission Dossier Preparation
Regulatory Strategy, Gap Analysis & Classifications
Label Preparation & Review
Regulatory Agency Interactions Support
US Agent Services and Senior Scientific Officer
Expedited Approval Pathways
Scientific Writing
Pre-clinical Toxicology Assessment and Support
Pharmaceutical Consulting Services:
Need help or have a question?
- China
- +86 21 5339 7903
- France
- +33 (0)2 78 94 01 78
- UK
- +44 (0)161 245 8071
- Japan
- +81 3 5643 8643
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