DSA Regulatory Affairs & GMP Consultants Team
Corina D'Sa – PresidentCorina has been with DSA since its inception in 1988. In her tenure with DSA, Corina has worked with over 150 clients and is well respected by Industry as an Expert in her field. Throughout her career with DSA she personally has submitted over:
She is a frequent industry presenter on various topics pertaining to drugs, medical devices, NHPs, and cosmetics. Corina has a solid grasp of Canadian regulatory requirements which allows her to excel in setting a Client's Regulatory Strategy with respect to product registrations, establishment licensing, and all dealings with Health Canada. Jamil Ahmad - Senior Regulatory Affairs ConsultantPrior to joining DSA, Jamil worked as a Manager of Regulatory Affairs for both Wyeth Pharmaceuticals and Wyeth Consumer Healthcare. Jamil handled a wide range of submissions to Health Canada and has particular expertise in the CMC Sections of a New Drug Submission, CTAs, Precursor Licenses, and Formulary Submissions. His career includes over 30 years of experience in the Pharmaceutical Industry, having held quality and regulatory related positions with Wyeth, Zeneca Pharma, and Smith Kline & French (now GSK). Jamil is a member of the TPD's Scientific Experts Inventory Database for Qualified CMC Reviewers. Charles Boampong - Senior Quality ConsultantPrior to joining DSA, Charles worked as a Quality Control Manager and QPIC with DC Labs where he was responsible for overseeing all activities related to sampling, testing, and releasing of bulk products, raw materials, packaging components, and finished products. Charles provided technical support to the method development and validation teams and was also responsible for reviewing and approving method validation, process validation and stability protocols. Charles audited contract laboratories and assisted with internal auditing of the facility. Before joining DC Labs, Charles also had a long career with Novopharm where he was responsible for stability, product release and formulation support. Ana Breivik - Regulatory ConsultantIn joining DSA, Ana brings many years of experience in working with Natural Health Products through her employment with Puresource Inc, a manufacturer and importer of NHPs. Prior to joining Puresource, Ana worked with the Human Neutraceutical Research Unit for the University of Guelph holding specific responsibilities in the areas of clinical trials, research ethics board applications, scheduling, and subject monitoring. Ron Frazer - Senior Regulatory ConsultantPrior to joining DSA, Ron with Glaxo SmithKline or GSK (including Glaxo Wellcome and SmithKline Beecham), holding the positions of Regulatory Compliance Manager, Regulatory Manager, and Regulatory Project Manager. Before joining GSK, Ron worked as a Regulatory Associate with Ciba-Geigy Canada (now Novartis). Ron started his career as a Pharmaceutical Evaluator with the Pharmaceutical Evaluation Division of Health Canada. Ron’s experience includes managing internal and external compliance requirements, managing C&M changes for both pharmaceuticals and biologicals, managing line extensions and servicing as a technical expert for C&M Submissions. Mitchell Kennedy - Senior Quality ConsultantPrior to joining DSA, Mitch worked with Torcan Chemical, an API Supplier, where he directed validation and stability programs, CMC drug substance submissions, drug substance APRs, and providing overall GMP and GLP guidance to the company and its clients. Prior to this, Mitch worked as a Compliance Specialist (Internal Auditing) with GlaxoSmithKline where his job function included establishing a Six Sigma Plan for tracking compliance improvement. Before joining GSK, Mitch worked with the Toronto Institute for Pharmaceutical Technology (TIPT) where he lectured in experimental design, sampling plans, GXP auditing, method development/validation, quality improvement and regulatory requirements. He has also performed GMP and GLP audits in pharmaceutical quality control laboratories, cosmetics manufacturers and finished pharmaceuticals plants and audited multinational clinical trials in Canada, United States and China. Sharon Krause - Senior Quality ConsultantPrior to joining DSA, Sharon worked as Quality Assurance Manager for Advantage Healthcare Packaging. She was responsible for ensuring overall compliance with Canadian GMP, managing the CAPA program, hosting client audits and managing the self-inspection program and the GMP training program. In earlier positions, Sharon has held responsibilities for batch record review, release of products including clinical supplies and management of QPIC duties for controlled substances. Her career includes almost 30 years of experience in quality-related positions with Advantage, Smith-Kline Beecham and Whitehall Laboratories. Estela Sansano - Senior Quality ConsultantPrior to joining DSA, Estela worked as a QA Team Leader with Alliance, a Proctor & Gamble Pack to order facility. She was responsible for maintaining Corporate SOPs and ensuring both GMP and HACCP compliance. Estela was responsible for Corporate Audits, Self-Inspection, Training, CAPA, Six Sigma Projects, Batch Record Review and Final Product Release to Proctor & Gamble. Her career includes almost 30 years of experience in quality-related positions with Alliance, Pfizer Canada Inc. (Searle Canada, Pharmacia & Upjohn, Pharmacia), Ace Packaging, Glaxo Canada (now Glaxo Smithkline) and Chempac Liquid. Our consultants come from a varied background of disciplines holding specialities in Chemistry, Human Biology, Immunology, Microbiology and Life Sciences. Additionally, Certifications are held as:
As a firm, we also hold memberships in the:
To receive detailed CV's or for more information on our Consulting Team and how we can be of assistance to you, please contact us for more information. |
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