QA and Regulatory Support
Statens Serum Institut (SSI) provides QA and regulatory support as part of on-site contract manufacturing projects exclusively.
Quality Assurance
The Quality Assurance (QA) department is an independent unit with highly skilled specialists. The quality management system is based on cGMP Guidelines for pharmaceuticals and biologicals, and is continuously adjusted to comply with current national and international requirements.
The QA department is responsible for assessment and approval for documents dealing with production and controls and perform batch record reviews and the release of the products.
The QA department is specialised in quality agreements.
Regulatory Support
We are committed to helping our customers to meet their product goals and provide regulatory support, including assistance with the compilation of CMC sections of a regulatory submission in both paper and electronic CTD format.
Our regulatory staff are experienced in:
- European Marketing Authorisation Applications
- IMPDs
- Investigational New Drug applications (INDs)
- Drug Master Files (DMFs)
- Biologic License Applications (BLAs)
Last revised 13 December 2011