Timothy Anderson

The AquaMarine Group, Inc. brings seasoned, diversified skills sets to its clients, 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. Services include review/writing of Chemistry and Manufacturing Controls (CMC) sections for NDA, ANDA, IND (biologicals and new chemical entities), PMA, eCTD, 505(b)(2), DMF, 510(k), Type I & II Var's.

Serving as Vice-President of Regulatory Affairs and Quality Operations for the “virtual” development-stage pain management firm, AlgoRx, Inc. (now, Anesiva), CMC, Formulation, QA/QC, and Regulatory filing management 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. • AdleaTM parenterally administered formulations of ultra-purified, and

Successfully guided, educated, and project managed the domestic and international regulatory and manufacturing functions within Sandoz, toward preparation and timely submission of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) to the FDA for Sandoz products, which have and/or are due to come off-patent. 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

Drafting deficiency or approval letters in the course of thorough review of chemistry and manufacturing controls sections of original and supplemental ANDAs and DMFs, resulting in fewer required review cycles for applicants. Sought and obtained expanded assignments at other FDA offices within the Centers for Drug Evaluation and Research (CDER), reviewing INDs and supplemental NDAs. Delegated with branch supervisory duties in the absence of the branch chief. Contributions to several policy-crafting CDER comm

Group leadership responsibilities, including the training and coordination of the assigned workloads of 8 technicians for the finished product and raw materials Quality Assurance laboratory. Recommendations implemented for equipment upgrades; delegated with laboratory supervision in the absence of managers.

Development of stability protocols and bioassay methods and validations, employed to determine drug and metabolite levels in plasma and serum in pre-clinical animal and clinical patient studies for newly developed drug formulae (Phases I and II). Preparation and group presentations of technical reports, detailing data, which linked chemistries to critical pharmacokinetic studies; editing of test methods of European subsidiaries to conform to USP protocols. Participation in DEA and FDA audits.

Thesis: "ECONOMIC NEW WORLD ORDER, Global models structured after those of the EC toward continued international economic integration: the Commonwealth approach for the emancipation of command economies and the historical and geographical bases for regional free trading zones in the furtherance of c

Thesis: "Synergistic reduction in proliferation of the histiocytic lymphoma cell line, U-937, by the combined action of recombinant interferon beta-ser and retinoic acid, and the associated changes in 2'-5' oligoadenylate synthetase and ribonuclease L activities."