Scientific mastery in a safe pair of hands

Draw upon the scientific power of Pfizer to shape your OSD development. 
As your trusted partner, we collaborate with you with the goal of optimizing your formulation and processes, working to reduce downstream risk and making peace of mind possible.

We have used our development expertise to overcome many technical challenges for our customers over the years, including:

  • Content uniformity for low-dose products
  • Solving coating challenges
  • 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

Opening the doors to opportunity

Clinical Phases

  • Development & manufacturing
  • Technical transfer
  • Formulation optimization
  • Scale-up/validation

Submission

  • CMC preparation
  • Final package
  • Pre-approval inspection

Launch

  • Drug to market
  • Production efficiency studies

Lifecycle Management

  • Cold-chain management
  • Supply/distribution
  • Drug delivery expansion
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Capabilities at a glance

Oral Solids

  • Early-stage formulation development
  • Process validation and optimization
  • Full development of analytical methods
  • Scale-up from lab to pilot to commercial
  • Specification development
  • Regulatory support - pre- and post-launch
  • Clinical manufacturing Ph I - III
  • Full range of OEB 1-5
  • Tablets, Capsules, Granules
  • Controlled substances (III - IV)
Let’s collaborate