Compliance Insight, Inc is pleased to introduce its biosafety testing consulting services for biologic pharmaceuticals and devices. Pharmaceutical and biotechnology companies may now benefit from a variety of new consultative services including:
•sterility, mycoplasma, and viral testing for raw materials, process intermediates and final products
•viral clearance and cleaning validation studies
•raw materials testing
•analytical and stability testing
Please contact us at 513-860-3512 to arrange a consultation.
New Whitepaper Added!
Is your virus study under control? We've just added a new whitepaper to our Virology Whitepaper Series that details key elements of control which support assay and virus study design. Our Virology Whitepaper Series contains the latest information on viral clearance study design and testing strategies for biologic pharmaceuticals. Please click here to access our library for free downloads.
Links to Regulatory Guidances
FDA GUIDANCE: Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
EMEA GUIDELINE: Virus Safety Evaluation of Biotechnological Investigational Medicinal Products
Compliance Insight, Inc. 513-860-3512 Copyrighted 2001 - 2011, Compliance Insight, Inc.
