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.