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We’ve traveled the route so often, we can steer you past common hazards and handle unexpected problems with confidence.

Our Newbridge, Ireland, facility has been manufacturing highly potent solid oral drugs for Pfizer for 25 years and for our third-party partners for more than 10 years. We have an onsite team who expertly executes smooth transfers into the site and can help you overcome many technical challenges that may crop up, such as:

  • Content uniformity for low-dose products
  • Resolution of process issues (e.g., tablet sticking or cracking)
  • Hard-to-procure commodities that could threaten launch timelines
  • Unexpected or unidentified impurities in the API
  • APIs that require complex processes

We’re intimately familiar with the regulatory landscape, too. Having practical regulatory filing knowledge of markets around the world, we can assist you in designing a regulatory strategy that helps you steer clear of mishaps and do-overs.

Our collaboration with you begins as early as Phase II. Technology transfer activities include:

Formulation optimization

  • Drug characterization for physical and chemical properties
  • Solubility and solution stability studies, including pH profiles
  • Excipient/compound compatibility studies

Analytical method development

  • cGMP-compliant laboratories
  • Impurities and degradation identification
  • Compendial method verification
  • Method development

Process development and optimization

  • Cleaning method development, validation and recovery studies
  • Comparability studies
  • Scalability studies
  • Process optimization and continuous process monitoring
  • Design of experiments to establish design space
  • Six Sigma methodologies used to solve problems and optimize processes

Regulatory support

  • Registration support and post-approval strategies
  • Regulatory agency inquiries and inspections
  • Lifecycle management support, such as new country registrations, scale-up and label-content changes