CONTRACTED REGULATORY AND QUALITY MANAGEMENT SERVICES

Timothy Anderson, MS, MBA, Principal, The AquaMarine Group, Inc. has served at various times in senior-level capacities as acting Director, through Vice President in contracted Quality and Regulatory management positions. He has advised evolving management structures for start up and virtual pharmaceutical firms, pharmaceutical services firms (CROs), and device firms. Management succession planning and contracted candidate interviewing and selection services have been furnished in the course of advising management re-structuring.

• PROJECT MANAGEMENT:  Sr. RA-CMC Project Management Consultant, redesign of Change Control management systems, RA-Quality- Mfg Change Control  Review board; RA management succession planning, department work-flow re-structuring. 

•  CONTRACTED SENIOR REGULATORY AND QUALITY OPERATIONS MANAGEMENT

As Vice-President of Regulatory Affairs and Quality Operations. AlgoRx, Inc. (now, Anesiva), a “virtual” development-stage pain management firm; CMC, Formulation, QA/QC, and Regulatory filing management is furnished to out-sourced domestic and international development units for three products in Phases 1, 2 and 3:

• Synthetic new chemical entity (NCE); pre-formulation studies -- proof of concept, and first in man trials.
• Filing of INDs, CTXs, staffing; external vendor selection, and cGMP compliance oversight, batch record review; international/domestic clinical study supplies management; regulatory strategy and Agency meetings.
• Accomplished senior level (i.e., Director and VP) staffing of regulatory and quality departments

As acting Vice-President, Regulatory Affairs, Taro Pharmaceuticals, USA, Inc., international (US, Israel, Canada)

• US, Canadian, and International filings; primary liaison for negotiations with Office-level regulatory bodies: bioequivalency, CMC, and application deficiency resolution
• Preparation of and approvals for 19 ANDAs, and 2- 510(k)s; amendments, supplements, and annual reports for approved products, 10 original DMFs, and 1  MAA for UK.
• Accomplished senior level (Director and VP) staffing of regulatory departments for Taro in Canada and NY.          

As acting Director, QA/Regulatory GMP/GLP, Oread, Inc. starting-up Oread's Rapid Response Laboratory, including SOP review/revision/composition, senior staff sourcing, establishment of laboratory GLP and GMP compliance systems, client support and regulatory liaison/advisory.

 

• AQUAMARINE GROUP AFFILIATE SERVICES
  

Affiliated consultants have acquired extensive middle and upper management experience in both big pharmaceutical firms and small, for ethical firms and generics, across drug, device, and biologics disciplines.

Like Tim, several affiliated consultants also have tenure with the FDA as review chemists, office directors, or as FDA district laboratories directors.