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ACCELERATING YOUR PHARMA BUSINESS
- GMACPHARMA have successfully guided companies through the late stage development and commercialisation of over 20 new drug products onto the US and EU markets.
- GMACPHARMA prepared a major US based CDMO (Contract Development & Manufacturing Organisation) for its double product PAI (pre-approval FDA inspection) during the commercialisation of two of its R&D pipeline products. The outcome was 0 citations from the FDA after 12 months preparatory effort by the cross functional teams.
- GMACPHARMA has worked closely with a number of CDMO’s across the world, to identify optimal manufacturing & analytical development partnerships and put in place robust commercial supply agreements that realised the commercialisation of multiple new drug products
- GMACPHARMA led an established R&D Therapeutics organisation through a number of extensive multiple investor syndicate due diligence processes – leading to the single largest round of funding in the country to support an ongoing clinical demonstration of a gastroenterology lead drug product asset, with multiple follow on therapeutic indications.
- GMACPHARMA led a start up Pharma biotech operation to successfully secure its GMP manufacturing and IMP licenses to enable future development of their clinical and commercial drug product pipeline.