If turnkey compliance sounds like a figment of the imagination, maybe you haven’t worked with Birchwood Contract Manufacturing. We have a compelling reason for you to trust our quality and high standards: At our facility, we develop and manufacture our own line of pharmaceutical products. When we work with you, the high standards and expectations we put into our products transfer directly into yours.
Our team has everything in place and ready to go in order to comply with FDA and EPA regulations. We know and understand what regulators are looking for. That means our contract will describe in clear detail how we’ll store and handle your materials. Throughout the process, we’ll provide all the necessary documentation to show how each step gets correct handling, monitoring and testing.
Our experience and well-established, above-board processes clear the way for a smooth validation and supplier qualification process. In the long run, we'll help you achieve the cost savings you expect from working with a contract manufacturer.
Your name is on the package, and your reputation is on the line. Why not work with a partner with a track record of doing it right?
What we do
From storing raw materials, to mixing, filling, testing and packaging, our facility is registered with the FDA and EPA, and our practices are in compliance with cGMP. What does that look like?
- Documentation system for historical reference
- Incoming inspection of materials
- Lab testing: HPLC, IR, pH, viscosity, specific gravity
- Validation of equipment, packaging and cleaning, including protocol reports
- Sterilization of packaged materials
- Visual inspection on manufacturing line
- Material/batch traceability
- Stability/expiration date traceability
- Label control recognition
At Birchwood Manufacturing, we understand and know the intricacies of the product manufacturing process, along with the details that need to be executed to get your product packaged and on to your end consumer.