Advisory and Support with Regulatory Affairs, Procurement, Outsourcing and Biomanufacturing including Cell & Gene Therapies and Vaccines.
- Routes to regulatory approval in key Asian markets with local knowledge with respect to PMDA (Japan), MFDS (Korea), NMPA (China), HA (Hong Kong), FDA (Taiwan), HSA (Singapore) and FDA (Thailand).
- Supply Chain, finding and working with suppliers and CDMOs
- cGMP gap-analysis, audits and reviews of pharma/biopharma, Cell & Gene Therapy, Vaccines and Med Tech. according to PIC/S, EMA and USFDA
- Facility design, URS, lay-out, engineering, construction, with all steps from CD, BD, DD through FAT, SAT, IQ, OQ, PQ, PV, CV etc.
- Recommendations in bioprocess development, including scale-up, de-bottlenecking and scale-down for biosafety testing.
- Implementation of single-use technologies for bioprocessing, Cell & Gene therapies, and vaccines for Drug Substances as well as fill and finish for Drug Products.