Process Validation Lifecycle Management Consulting Information

We are leaders in the complex world of biologics development, qualification and regulatory approval. Empower your project with comprehensive expertise, tailored support, and knowledge from experts who have completed these activities countless times. We offer a unique blend of training and consulting services which focus on industry best-practices that eliminate filing delays while balancing compliance and practicality. We can support any biologic product, from any cell line, and with any mechanism of action. Go to www.PVLMC.com to discover how we can support your projects. We can provide on-site or remote consulting services. We are experts in all stages of process validation, CQA determination risk assessment, PPQ readiness, quality system design and harmonization, PAI preparation, quality system or pre-acquisition due-diligence auditing, and regulatory filings. In addition to providing tailored support, we also offer unique pre-built biopharmaceutical eTraining courses and eTools which include best-practices designed by our CEO. Our executive consultants each have ~25 years of experience in biologics and have secured approval of monoclonal antibodies (mAbs), vaccines, recombinant proteins, interleukins, sublingual immunotherapies and biosimilars. We’ve worked for four different Fortune 500 biologics companies, gaining approval of two of the largest blockbuster biologics ever approved (Enbrel® and Keytruda®). We’ve secured approval of nearly 10% of the more than 250 biologics which have been commercially approved to date. We have gained approval of multiple drugs with FDA breakthrough designation, accelerated approval, priority review, and orphan drug designation. We have an exceptional rapport with all regulatory agencies and have twice had our studies retained by the US FDA as model examples. We also supported the US FDA Coronavirus Treatment Acceleration Program (CTAP).