Todd Kessler Email & Phone Number

Go to www.PVLMC.com to discover how we can support your projects.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.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.

Listed skills include Validation, Quality Assurance, Biopharmaceuticals, Gmp, and 11 others.