VelaLabs – consulting partner not only for GMP topics
Companies manufacturing formulated pharmaceutical products, biotechnology products and active pharmaceutical ingredients (API) must meet prescribed standards of Current Good Manufacturing Practice (cGMP).
VelaLabs offers consultancy on the following topics:
- Current Good Manufacturing Practice (cGMP)
- Current Good Clinical Laboratory Practice (cGCLP)
- Clinical development
- Quality management
- Method qualification and validation
- Method transfer
- Regulatory agency documentation
- Advisory support for submission-relevant clinical studies and drug product release
- EU batch release
- Scientific advice meetings
Moreover, due to the wide-spread experience of its workforce VelaLabs is also able to offer consultancies in the following areas:
- Audits (advice and on-site auditing)
- Biosafety
- Competitive intelligence