CMC Development and Manufacturing Strategies
Hayat Pharmaceutical Consulting (HPC) has substantial experience and expertise in developing CMC development and manufacturing strategies for small/large molecule and Advanced Therapy Medicinal Products (ATMP) that are fully integrated, smart and customized to the product development, regulatory, manufacturing and customer needs.
CDMO/CRO Search and Management:
HPC team can perform for our clients the search and selection process of CDMO/ CROs. We can lead contract negotiation for clients, manage and oversee the CMC development and GMP manufacturing from pre-clinical into late-stage development for small/large molecules and ATMP products at multiple CDMOs/CROs and third-party laboratories for our clients.
GMP Manufacturing:
HPC has broad and deep experience and expertise in clinical and commercial GMP Manufacturing. We have managed tech transfers and oversee the manufacturing from pre-IND clinical, to late stage, launch, and commercial manufacturing at multiple CDMOs and contract manufactures.
Process Design and Optimization:
Based on our experience, we have helped our clients to develop well-defined scopes, realistic budgets, and timelines for their project. We performed process design, optimization, validation and scale up to commercialization.
Due Diligence
HPC team has performed multiple due diligence projects in CMC development, GMP Manufacturing, Reg. Affairs, and QC/QA area for Investment, Private Equity, and Biopharmaceutical companies.
