We are a team of biopharma industry experts that assumed executive roles in various international biotech companies.
We have a successful track record of biological products clinical supply & commercialization (MAA/BLA) together with strong process / regulatory / quality control & quality assurance background.
We offer consulting services of following key areas:
Pre-clinical/clinical & commercial mammalian and microbial products development & manufacture, including recombinant vaccines
Biologics GMP compliance, GMP audits and pre-approval inspections readiness
GMP facilities for biologics design & engineering solutions
Biopharma business functions support