QUALITY OPERATIONS

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

• GLP/GCP AUDIT SERVICES

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.

• MANUFACTURING VALIDATION

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