Life Sciences Regulatory Affairs
A multi-disciplinary team of qualified regulatory affairs experts to support you in all regulatory aspects of the clinical development of your medicinal product.
To speed-up market access for your medicinal products including trial and marketing authorisation applications, you need to ensure strict adherence to all regulatory requirements. Our regulatory affairs services help you explore the shortest route and timeframe to put your products on the market safely. We provide vital support to help you meet international and regulatory standards as you progress from preclinical testing to clinical trials.
Our experienced multilingual team works closely with worldwide regulatory agencies and is available for temporary regulatory support on your site.
Why choose regulatory affairs services from SGS?
We offer you:
- Regulatory expertise during the full clinical development, including the development of all regulatory documentation
- Collaboration and coordination with local and global cross-functional teams
- Adaptation to your specifications, including varying operating procedures
World-class regulatory and scientific services
Our regulatory and scientific services include:
- Consultancy on medicinal products in development, generics, biosimilars, bibliographic submissions and orphan drugs
- Strategic regulatory advice
- Non-clinical regulatory guidance
- Clinical trial submissions (CTA IND)
- Development of CMC documents
- Development of Investigators Brochures (IB)/non-clinical overviews
- Development of clinical overviews
- Support in meeting with health authorities (FDA, EMA and National Competent Authorities in Europe), including development of the briefing package
- Pediatric Investigational Plan (PIP)
- Orphan Drug Designations (ODD)
- Response to requests from regulatory authorities
To discuss how we can help with your regulatory requirements, contact us today.