What We Offer
Biomed Innova offers a full spectrum of services. We approach every engagement with a customized plan that satisfies the unique needs of the client. We also fully support regulatory and cGMP compliance requirements.
Biomed Innova is committed to meeting the highest level of quality standards throughout all of its activities. Our quality programs are designed to eliminate errors, to ensure the accuracy of all results and to meet the compliance requirements of our clients.
Regulatory and cGMP Support
There are many FDA regulations that impact drug production. The FDA’s mission is to ensure that safe and effective new drugs are available as quickly as possible and that existing drugs remain safe and of the highest quality for as long as they are on the U.S. market. The FDA has announced its intention to vigorously enforce requirements in place to ensure this mission. Biomed Innova is prepared to help you meet those regulations.
- Compliance with cGMP and GLP regulations
- Ongoing monitoring of changes to regulatory requirements
- Continual interaction with customer quality groups to ensure projects are compliant
- Documented training for all Biomed Innova employees
- Strict document review and approval procedures
- Procedures for the receipt and handling of samples and raw materials
- Vendor qualification
- Instrument qualification, calibration and maintenance programs
- Routine internal audits
- Data integrity systems
- Management of events with change control and CAPA procedures
Our team is ready to give you all the support and guidance needed to complete your testing project. We regularly work with pharmaceutical, life science, biotech and nutraceutical companies as well as researchers, 503B outsourcing facilities and 503A pharmacies.