Chemical Development Solutions
We ensure quality in the process during the design and development phase by understanding the Critical Process Parameters (CPP) and Critical Material Attributes (CMA).
Custom synthesis, including synthesis of reference standards, impurity markers and scaffolds, with rapid turnaround and competitive pricingProcess safety assessment to proactively identify potential hazardous reactions Rich experience in developing innovative process for the NCEs
10+ IND filing support/ year
Scientists have an average of 12+ years of experience in process development
18 molecules in late stage/commercial
7 programs in Phase III for a top 3 pharma companies
Cater to various sectors such as pharmaceutical, specialty chemicals and animal health industry
Our facilities have been inspected and accredited by several global regulatory authorities and major pharma clients. Some of the authoritative bodies include FDA, European Directorate for the Quality of Medicines (EDQM), Ministry of Food and Drug Safety, Pharmaceuticals and Medical Devices Agency (Pmda)
More products from GVK BIO
Contract Manufacturing Solutions
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 proc...
Formulation and Analytical Solutions
GVK BIO offers a range of Formulation R&D solutions that include pre-formulation studies, formulation development, analytical R&D, reformulation and stability studies. We can also support clinical supplies and manufacturing of exhibit batches in collaboration with our partners and offer standalone ana...More info
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