GVK BIO offers a range of Formulation R&D services that include preformulation development, formulation development, analytical R&D, reformulation, stability studies, clinical supplies and manufacturing of exhibit batches*. We also offer standalone Analytical services for third party formulation products.
Our Regulatory team has a good understanding of the regulatory aspects of Formulations development. The team brings to the table their global experience and expertise for preparation and submission of ANDAs, INDs and NDAs.
Our objective is to provide a robust, production friendly formulation in shortest development time while incorporating best practices and adhering to stringent regulatory compliances. We focus on ensuring every stage of product development is successful. Our expertise lies in overcoming the challenges faced during studies of flowability, solubility, selection of drug-excipient combination, dissolution profiling, impurity profiling, bioavailability and bioequivalence.
* Clinical supplies and manufacturing of exhibit batches are done with a partner