Formulation
Development
Solutions

Expedite time to market, reduce development cost and access to specialized expertise

At GVK BIO, we recognize the importance of our clients’ requirement to develop robust and compliant drug products. Our diverse capabilities help accelerate our customers R&D and ensures speed to market.

  • Our formulation development team has extensive experience in different dosage form development for both New Chemical Entity (NCE) as well as generic product development applying our technical skills, efficiency and quality consciousness to develop robust products
  • Our expertise lies in overcoming the challenges faced during formulation development and offer solutions to overcome flowability, solubility, wettability, dissolution, degradation, bioavailability issues encountered during development
  • Our team has successfully delivered products enabling our clients to conduct clinical studies and file products in different markets
  • Our team comes with strong drug product analytical expertise and QbD study designs

Our formulation development solutions focus on both NCE as well as generic formulations fulfilling regulatory requirements of target markets to achieve quality attributes and performance metrics set by clients. We provide end to end solutions from pre-formulation to manufacturing with partners to enable our clients file IND, NDA or ANDA with regulatory authorities.

We help pharmaceutical companies to successfully resolve issues in a variety of dosage forms / products and enable faster regulatory approvals.

Our offering includes:

Pre-formulation studies

  • Drug substance / API characterization
  • Drug excipient compatibility studies
  • Container closure compatibility studies
  • Stress stability studies
  • Analytical method development
  • Deformulation studies
  • Dosage form enabling studies

Dosage Form Development

  • Tablets (immediate and modified release)
  • Capsules (powder and pellet)
  • Liquid oral formulations
  • Injectable and ophthalmic formulations
  • Complex injectable formulations
  • Semi solid formulations
  • Analytical method validation
  • Stability studies

Brochure

Formulation & Analytical Solutions

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Whitepaper

Developability Assessment of Small Molecules

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