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The AquaMarine Group Inc
148 Gallows Hill Road
Since 1996, The AquaMarine Group, Inc.â€™s services have been sought and retained by pharmaceutical firms, to furnish expertise in the areas of regulatory review, application writing, cGMP compliance/mock pre-approval audit services, R&D portfolio analysi
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(31 Total References)
Aqua Marine Group | Contracted Management
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.
Aqua Marine Group | 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.
Aqua Marine Group | 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.
Aqua Marine Group | About the Principal
Timothy A. Anderson, MS, MBA
career spans 28 years in the pharmaceutical/consumer products industries.
brings diversified academic and scientific credentials: 8 years in formulary and analytical R&D, 8 years in pharmaceutical Quality Control/Quality Assurance, and 18+ years in pharmaceutical Regulatory Affairs, the latter which embodies tenure at FDA
as a Review Chemist.
Post-FDA industrial officerships held have included serving as division Vice-President, Regulatory Affairs (Creighton Pharmaceuticals, Sandoz), prior to forming his
own consulting firm, The AquaMarine Group
Tim was also invited to serve in the capacity of Vice-President of Regulatory Affairs and Quality Operations for the "virtual" pain management pharmaceutical development firm, AlgoRx Pharmaceuticals, Inc.
FDASmart 60-Minute Webinar on Pharmaceutical Emerging Regions Series
Tim Anderson - AquaMarine Group (former US FDA CMC Chemist/Reviewer- CDER)
Tim Anderson is a CMC expert who served with the US Food and Drug Administration (US FDA), CDER as a Review Chemist in 1992.
In this capacity Tim
reviewed and granted approvals for Chemistry and Manufacturing Controls (CMC) submissions (ANDAs) at the Office of Generic Drugs.
has developed a set of discipline and check-list to assist you with CREATING AND MAINTIANING a cGMP mindset that only a former US FDA insider can.
: - AquaMarine Group
(former US FDA CMC Chemist/Reviewer- CDER)
has 28 years in the pharmaceutical/consumer products industries.
brings diversified academic and scientific credentials:
Post-FDA - Tim held various positions include serving as division Vice-President, Regulatory Affairs (Creighton Pharmaceuticals, Sandoz).
The AquaMarine Group, Inc. formed by Tim brings seasoned, diversified skills sets to client projects, reducing overall costs of pharmaceutical and consumer sector regulatory compliance: maintaining/improving the client's profit margin, while remaining comfortably within expectations of global regulatory health authorities