Small Molecule Injectable Development

Oakwood’s expertise in the small molecule injectable development business can assist your organization with challenging aspects of product development.  Oakwood’s strength is a combination of years of experience, quality, and attention to detail. We take a systematic approach towards development while taking into consideration today’s expectations for the finest quality product intended to meet FDA’s stringent requirements for approval.

Capabilities

Our knowledge, experience and insight is unrivaled in an effort to develop a quality product sufficing the needs of a constantly evolving pharmaceutical industry.  Oakwood’s uniqueness is further exhibited in our ability to manufacture products in our cGMP facility. Oakwood offers the following:

  • formulation development
  • analytical method development
  • lyophilization cycle development
  • method validation
  • remediation activities for existing products
  • life-cycle management
  • shelf-life stability studies
  • method transfer
  • establishing the CPP’s (critical process parameters)
  • protocol and report writing expertise
  • aseptic manufacturing
  • microbiological testing
  • quality control activities
  • manufacturing of commercial batches and clinical trial material

Oakwood can also work with you on development of your sustained-release injectable product.