Contract Manufacturing and Pharmaceutical Outsourcing

Contract Manufacturing

Getting your product to market quickly and efficiently is crucial to your success. Outsourcing to a contract manufacturing organization such as McGuff Pharmaceuticals will provide many opportunities to streamline your pathway to market.

Pharmaceutical outsourcing lets a sponsor company focus on its core business by having manufacturing and regulatory functions assumed by McGuff Pharmaceuticals. Freed from devoting energy to areas that are not in its expertise, the sponsor company may focus its resources on meeting its customer’s needs or continue productive research in its chosen field.

Pharmaceutical outsourcing becomes increasingly important as sponsor companies search for ways to bolster productivity and keep down fixed costs.

McGuff Pharmaceuticals is experienced and understands the technical and regulatory impediments along the drug development path. We will leverage our understanding of the manufacturing process and regulatory environment as we develop the sponsor company’s products. To that end we have a proven capability of developing a process and operational strategy that is robust, scalable and financially sound to meet the commercial manufacturing needs of our sponsor. A small sampling of what McGuff Pharmaceuticals can offer includes:

  • Assess risks
  • Provide pilot batch through commercial manufacturing capability
  • Make cGMP assessments and guidance
  • Provide process development to reduce process variability
  • Provide validation strategies
  • Provide API raw material sourcing and quality acceptance
  • Develop a manufacturing plan
  • Develop cost estimates based on need
  • Conduct Failure Mode Analysis (e.g. FMECA and FTA)
  • Perform gap analysis
  • Establish timeline estimates

At McGuff Pharmaceuticals, we listen to you first. We understand that the successful completion of any outsourcing project depends on a close, flexible and results-driven relationship between all parties.

We are here to help. Let us show you how.

Additional Information Request

Thank you for contacting McGuff Pharmaceuticals, Inc.

Your request has been received and is being reviewed. You will receive a response within 1 or 2 business days.

Please call (800) 603-4795 with any immediate questions.