A Black Diamond client is looking for an Export SME to help them ship API from EU to UK, and then Drug Product from the UK to the US. The first batch of product due to ship in the next couple of weeks is raw material for R&D batch. Animal derived product from a GMP certified facility. They are looking for someone with extensive experience with the regulatory paperwork and contracts to export out of the EU and UK. Eventually they will need help shipping the finished drug product from the UK to US.
- Familiarity with FD&C Act Section 502 and 801
- ICH Q7A
- 21 CFR 201.122 and 312. 160
- 505 (b)(2) Regulatory pathway
- Certificate of Medicinal Product (CMP), MAA, Article 58 Regulation (EC) No 726/2004
Remote: Drug Product Export SME (229555)