Formulation

We have the experience and the world-class lab talent to find creative solutions for taking your drug and developing a stable, viable formulation. We’re able to:

  • Product concept screening, design, and selection that focus on pre-formulation
  • Assess the feasibility of delivering the drug
  • Conduct rapid screening and characterization of raw materials
  • Leverage novel particle engineering techniques
  • Evaluate drug/device interaction
  • Develop and refine the delivery system, including Inhalation Drug Delivery, Transdermal Drug Delivery, and Intradermal Drug Delivery
 

Product development

An inventive spirit and tenacious problem-solving attitude have led to a long history of drug delivery firsts, including the first metered-dose inhaler and the first drug-in-adhesive patch. We’re able to:

  • Finalize product design and complete method validation
  • Characterize in vitro performance of drug product
  • Design a clinical plan
  • Lead and support pilot and pivotal clinical studies
  • Develop and register an application with regulatory authorities
Kindeva Product development
 

Scale-up manufacturing

We pair a deep understanding of device and drug quality systems requirements with pharmaceuticals manufacturing—making your product a reality while being compliant.

  • Develop manufacturing process at the desired scale
  • Support clinical trials and a regulatory data package
  • Demonstrate process performance through process validation
  • Manage supply chain with respect to API and component sourcing
kindeva scale-up manufacturing
 

Commercial manufacturing

To ensure your product meets global compliance standards, our commercial manufacturing process combines extensive knowledge of device and drug quality systems requirements with pharmaceuticals manufacturing expertise, including:

  • Enacting a product’s control strategy
  • Establishing a quality agreement with our client
  • Maintaining process performance
  • Assuring continued compliance with ever-evolving regulatory standards
  • Managing supply chain with respect to API, component sourcing, and packaging
Commercial manufacturing

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