Activities that can be performed include, but may not be limited to:
Regulatory affairs
- Gap analysis of module 3/IND/CTA relative to development stage of product
- Authoring of module 2 & 3 (CTA/IND or MAA/BLA)
- Scientific advice briefing package review/authoring, including support at scientific advice F2F meetings if needed.
- Regulatory strategy for process changes pre- and post-approval
Product / process development
- Process development and product characterisation strategy throughout clinical development and through to commercialisation
- Clinical and commercial supply strategies
- Scale-up/scale out strategies
- CDMO selection and tech transfer activities
- Product comparability evaluations
- Process qualification / validation strategies
- Stability study designs
- Specification setting
Analytical assay development
- Assay development / qualification / validation strategies
CMC due diligence for potential M&A