Since our inception in 1997, Oakwood Labs has become a world leader in the development and manufacturing of sustained release parenteral products. We have gained this expertise by hiring highly skilled and knowledgeable staff within the industry. Oakwood specializes in two primary business offerings.

1. Patented Chroniject™ technology platform for developing long acting injectables. Through this technology, we offer a one-stop shop from initial feasibility through clinical trials and FDA approval.

Lyophilized pharmaceuticalsContract Development and Manufacturing (CDMO) expertise includes:

  • Pre-formulation activities
  • Feasibility studies
  • Scale-up of formulation
  • Manufacturing toxicology batches
  • ICH compliant stability testing
  • Clinical trial manufacturing (Phase I, II, III)
  • Commercial aseptic GMP manufacturing
  • CMC and regulatory support
  • Analytical method development and validation

2. Contract manufacturing services, which leverages our FDA approved GMP facility for production of sterile injectable products.

PLGA microspheresContract Manufacturing (CMO) expertise includes:

  • Technology transfer capabilities
  • Manufacture of sterile injectable products
  • Aseptic production capabilities
  • Ability to manufacture lyophilized products
  • Ability to handle high potency compounds
  • Quality control microbiology and chemistry
  • ICH compliant stability testing
  • Regulatory support and CMC section filings