- Coordination of development of generic drugs for EU including coordinate pharmaceutical development, planning, coordination and monitoring of bioequivalence studies and up-scaling from laboratory to pilot and production scale.
- Support with GCP, GMP and GDP audits and authority inspections.
- EU submissions incl. compilation of CTD dossiers for human and
veterinary medicines, and running Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition
Procedure (MRP) or national procedures.
- Guidance in the requirements for food supplements, strong vitamins and minerals, medical device, traditional use medicines, herbals, and medicinal products.
- Implementation and compliance with Quality Management Systems in compliance of GDP and GMP and the requirements for euphoriant drugs.
- Guidance and implementation of the EU FMD directive on all levels from production site, MAH, EMVO and NMVOs to pharmacy level.
- I can offer the role as QP and responsible person.
