Chemical
Development
Solutions

Fit for purpose : Early to late phase process development

Chemical Development Solutions of GVK BIO provides a convenient, single-site distribution of infrastructure, thereby delivering a seamless and innovative transition of solutions from lab to pilot plant and bulk manufacturing, with speed and quality.

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 pricing
  • Process 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)

Offerings:

Equipped with advanced process chemistry, process safety and analytical instrumentation, GVK BIOs team of scientists supports all your chemical development needs, offering integrated, continuous service through the drug development life cycle.

Our Chemical Development solutions include:

  • Synthetic route scouting
  • Process development and QbD based process optimization
  • Analytical method development and validation
  • Process simulation and safety studies
  • Process implementation
  • Scale up to pilot/commercial scale
  • Evaluation and control of potential genotoxic impurities
  • Salt screening / crystallization
  • Polymorph evaluation
  • Scale-up and regulatory compliant manufacturing
  • Technology transfer
  • CMC documentation support
  • Quality and On Time In Full (QOTIF) delivery
  • IND Filing/ DMF document support

Brochure

Chemical Development Solutions

Download the Brochure

Whitepaper

Developability Assessment of Small Molecules

Download the Whitepaper