REGULATORY AFFAIRS 

Timothy Anderson, MS, MBA, Principal, The AquaMarine Group, Inc. furnishes his primary services from the perspective of a former review chemist with the FDA. These services include review and writing of Chemistry and Manufacturing Controls (CMC) sections for NDAs, ANDAs, INDs (biologicals and new chemical entities), DMFs, 510(k)s, NDSs, ANDSs, MAAs/CTXs and International filings (CTD). Drug-device combination product filings.

Research and Development

Tim furnishes strategic planning and formulary development project management services in the following areas: Analytical and bioanalytical development guidance and evaluation. Chemistry and Manufacturing (CMC) stability profiling evaluation and guidance. Master Batch Record development and advisory. Executed Batch Record review and deviation reporting advisory.

• DRUG-DEVICE COMBINATION PRODUCTS:  Sr. CMC Consultant to IND, IDE, CTA, PMA and NDA filings.

  ZingoTM  (ALGORX-ANESIVA PowderJect® lidocaine) needle-free anesthetic.  Drug-device 505(b)(2) NDA approved 2007                  
               
  Endeavor® Zotarolimus drug eluting stent (MEDTRONIC AVE),
  PMA approved 2008

• NDA, ANDA, and DMF FILINGS

           AdleaTM (ALGORX-ANESIVA) parenterally administered formulations
           of ultra-purified, and synthetic Capsaicin (Phase 3 trials).
             
           Micarids HCT® (BOEHRINGER INGELHEIM) co-formulation and site            change.  NDA approved 2000.
             
           Clozapine Tablets and Drug Master File (SANDOZ Clozaril®) 
           ANDA approved 1995

                     First US generic product to employ a patient-based bioequivalence                      study

                    First time generic product approved in 7 months from its first filing   
   
                     Cyclosporine Capsules and Drug Master File (SANDOZ Sandimmune®)                      ANDA approved 2000 

                      > 20 ANDA filings, and 15 Drug master file preparations

• AQUAMARINE GROUP AFFILIATE SERVICES

  AquaMarine Group, Inc., fields its affiliated consultants on assignments in related disciplines:

  • Medical devices and combination products services
  • Formulation, Batch record, documentation composition, and review services
  • SAS training, filing review services
  • Bioequivalence advisory services