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Bio-Concept provides proven know-how for every development project.

Bio-Concept is committed to maintaining the highest quality while meeting client objectives in the most time and cost efficient manner. Our development team applies its extensive sterile product development experience in finding effective solutions to your unique challenges.

We take pride in guiding and supporting our clients at every step of the drug development process.

Process

Preclinical Development:

  • Formulation Development
  • Analytical Development
  • Stability Screens
  • Microbiological Testing

Clinical Support:

  • Pre-IND support
  • IND CMC Section
  • Clinical Manufacture
  • Stability Testing

Process Research:

  • Process Scale-up
  • Container / Closure Evaluation

Bio-Concept has an integrated product development program designed to bring your new product to market efficiently and effectively. The status, strategy and assumptions are routinely reviewed with the client and modified as appropriate. Each project is assigned a project coordinator to give you and your project the personal attention both deserve.

Ophthalmics:

Our expertise in the development of ophthalmic formulations allows Bio-Concept to anticipate and address challenges that are unique to ophthalmic products. We offer specialized insight into preservative systems, buffers and other excipients. Our flexible hand-fill process allows us to address a variety of fill volumes and container options.

Liquid Injectables:

Bio-Concept has over 25 years of experience with Parenterals from small molecules to larger polymers and proteins. Our customized development process and hand-fill manufacturing promotes conservation of API during the early stages of development.

Bio-Concept provides all the Development Steps necessary for you to efficiently go from API to IPO.

Capabilities

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