SGS’s regulatory and medical affairs team is at your disposal for all regulatory aspects of your marketing authorisation applications for human and veterinary medicinal products. We also provide comprehensive and flexible solutions for the active management of drug safety and risk management during the complete life cycle of a medicinal product.
Regulatory affairs services
Full regulatory support services from pre-clinical to post-marketing
Experience in numerous product types:
– Classical drugs
– Herbal products
– Recombinant-DNA
– Oligonucleotide products
– Vaccines
– Blood derivatives
– Cell and gene therapy
Regulatory monitoring of the IMP (investigational medicinal product) development plan, including the set-up of good research practice
Overall guidance and consulting for setting up the EU regulatory strategy
Gap analysis of US BLA’s for compliance with EU requirements
Comprehensive country specific submission guideline
Medical affairs services
- Set-up and maintenance of a safety database
- Serious adverse event management
- Expedited reporting
- Annual safety report writing
- Eudravigilance registration consultancy
- 24/7 availability
- In-house serious adverse event management/expedited reporting
- Medical monitoring
- Report writing (annual/periodic reports, expert reports, safety summary, IB/CCDS updates)
- Safety analysis and risk management
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