Park Avenue Group
Consultants with years of experience in Quality Assurance, Quality Control, Compliance and Regulatory. Extensive industry knowledge with domestic and international experience in Biotechnology, Pharmaceutical Sterile manufacturing, CAR-T, Nutraceuticals, Food, USDA and Contract manufacturing sites such as Pfizer, Eli Lilly, Sanofi , J&J and more. Areas of expertise also include Laboratory Operations, Inspection Readiness, Quality Systems, and Process Improvement. Skilled at conducting laboratory and facility audits, compliance training, batch assessments, playing a key role in the implementation of Quality Systems & ensuring completion of regulatory commitments.
Involved successfully in consent-decree, NDA, lifting of import alert, remediation of warning letters, batch assessments for release to the US market & Pre-Approval Inspection projects ensuring completion of commitments.
Involved successfully in consent-decree, NDA, lifting of import alert, remediation of warning letters, batch assessments for release to the US market & Pre-Approval Inspection projects ensuring completion of commitments.