STM Pharma has a team of accomplished consultants with a strong and successful track record and extensive industry experience in a variety of leadership and management roles in various large and small pharmaceutical and biotechnology companies, both innovative and generics. The range of services includes: full CMC development of parenteral and other sterile drug products, topical drug products, oral dosage forms, antimicrobial drug products, and in all aspects of microbiology.
STM Pharma also offers consulting services in the design/renovation of facilities and in resolving technical, operational and GMP compliance challenges faced by Compounding Pharmacies.
STM Pharma also offers expertise in the preparation, review and submission of regulatory documentation, (IND, NDA, 505(b) (3) and ANDA); and in assisting client companies (who may have received 483s or warning letters) in addressing and resolving any CMC or microbiology deficiencies.
In addition to the above, STM Pharma offers project management services to assume full responsibility of the project from inception thru full development, tech transfer, regulatory submission and commercialization on behalf of the client.