Cost-effective and commercially viable technology development, validations and commercial manufacturing with flexible business model to meet customer end needs

GVK BIO offers long term Contract Manufacturing Solutions in development, validations, DMF filing, manufacturing of New Chemical Entities (NCE), Active Pharmaceutical Ingredients (API) and Intermediates.

Capabilities:

• Environment friendly routes under GMP conditions
• Robust and cost-effective processes
• Seamless technology transfer
• Diverse scientific team
• Strong scientific team with generic manufacturing focus
• Intellectual property protection
• DMF filing and life-cycle management
• Global Regulatory Accreditation – USFDA, EDQM, PMDA, Korean DMF, WHO GMP (CDSCO/DCA), ISO 9001: 2015, NABL accreditation

We have the following flexible business models to support various client needs:

• CRDM (Contract Research, Development and Manufacturing): Technology development, optimization, transfer, validations and DMF filing, followed by commercial manufacturing
• CRD (Contract Research and Development): Technology development, optimization and technology transfer
• CM (Contract Manufacturing): Technology absorption and commercial manufacturing

Our manufacturing expertise is designed to handle a wide range of operating conditions in commercial scales.

Our commercial manufacturing facilities are co-located with our pilot plant, providing end-to-end solutions from feasibility phase in R&D to commercial supplies, including DMF support.

Our process development, technology transfer and commercial execution teams collaborate seamlessly to provide concept to commercialization timelines.

Our Project Management team coordinates between the cross-functional teams and also with the customers to ensure the seamless execution of the projects.