Trusted analytical testing and research services support your development, approval and manufacturing of pharmaceutical, biopharmaceutical and animal health products. An experienced team of scientists works with you to design a comprehensive solution to meet the timing, measurement and data requirements specific to your project and regulatory considerations.
Microbac provides quality and safety testing throughout the product life cycle for large and small molecule drugs. We have decades of experience working with pharmaceutical and biopharmaceutical products in compliance with GLP and cGMP regulation. Our laboratories are registered with the FDA and DEA (Schedule I-V controlled substances) and are ISO 17025-accredited.
Working with pharmaceutical companies large, small and virtual, we offer methods development and validation, process validation, investigation, product development support and cleaning validation for prescription, generic, OTC, animal health, compounding pharmacies and more. From raw ingredient testing to navigating the complexities of regulation, our team works with you to ensure ease and confidence throughout the product life cycle.
Due to the inherent risks of biopharmaceuticals - vaccines, monoclonal antibodies, recombinant proteins, blood derivatives, animal tissue derived products, etc. - a variety of quality and safety testing is required by the FDA. Our industry experience and deep knowledge in this industry will help ensure the ultimate safety and compliance of your product.
Regulatory guidance and testing: