Timothy Anderson, MS, MBA, Principal, The AquaMarine Group, Inc. performs internal, supplier, and outsourced partner cGMP compliance audits, mock-pre-approval inspections, as conducted from the perspective of a former FDAer. Standard Operating Procedure composition. "Crisis management" advisory. FDA warning letter responses, Corrective and Preventative Action (CAPA) system development. Out-of-Specification (OOS) investigational report preparation and regulatory advisory. Consent decree remediation plans.
- QUALITY SYSTEMS: Sr. Consultant
- MEMORIAL SLOAN-KETTERING CANCER CENTER establishment of a regulatory & cGMP compliant quality system for 11 Clinical Investigator's laboratories and API synthesis. IND/NDA preparation and review (biologicals, radio-labeled peptides, devices, and new chemical entities), batch record composition and review, documentation and vendor audit, SOP composition, and crafting of a management structure to administer Regulatory/Quality functions.
- CONSENT DECREE REMEDIATION Sr. Compliance Consultant
- WYETH Consent Decree 2000
- GLAXO SMITH-KLINE Consent Decree 2006
The AquaMarineGroup, Inc., and its affiliate consultants conduct GCP and GLP audits for completed toxicology, pre-clinical and clinical studies.
- DUE-DILIGENCE AND QUALITY SYSTEMS
The AquaMarine Group, Inc., and its affiliate consultants conduct internal, supplier, and outsourced partner due-diligence and Quality Systems audits.
The AquaMarine Group, Inc., and its affiliate consultants furnish manufacturing validation services for scale-up pharma and combination drug device production.
- Manufacturing and scale-up, manufacturing training
- Canadian cGMP and Quality Systems, and International regulatory advisory services
- Innovator, Generic, and OTC Formulation development services
- Formulation, Batch record, documentation composition review and creation services cGMP Training, cGMP audit services, regulatory filing services
- Quality Operations advisory services