Our Experts

Dr. Mary Mazur-Melnyk
COO, BioReg International

Dr. M. Mazur-Melnyk, has over 20 years experience in the areas of bio/pharmaceutics and medical devices and has held senior management positions both in Quality Assurance and Regulatory Affairs. She holds a M.Sc. in Medical Sciences and a Ph.D. in Molecular Biology. Currently she is the COO of BioReg International (BRI) - a leading global regulatory systems solutions provider to the healthcare industries. BRI is focused on providing reliable service and lasting solutions from basic regulatory, quality and product support to the most complex registration and compliance issues.

Dr. Richard Pike
Consultant

Dr. Richard Pike has over thirty years of experience in the pharmaceutical industry. Most recently, he served for over ten years as Senior Vice President of R&D and Regulatory Affairs at Genpharm, a subsidiary of Merck KGaA, where he was responsible for overseeing development of over fifty-five products for submission into USA, Canada, and European dossiers. Dr. Pike also worked at Health Canada for many years, first as a Research Scientist in the Pharmaceutical Chemistry Division for the Bureau of Drug Research, and subsequently as Senior Drug Evaluator for the Therapeautic Programmes Directorate (TPD). Prior to joining Health Canada, he served as Director of Clinical Research at Stiefel Laboratories and Director of the Bio-analytical Laboratories at Bioresearch Laboratories. He began his career as a synthetic medicinal chemist. Currently, he is a consultant to the pharmaceutical industry, helping companies with their GMP, GCP and GLP areas and strategies for effective R and D.

Mr. Andrei Ponomarev

Mr. Ponomarev is the Principle Associate at APPCA(AP-Pharmaceutical Consultant Associates) with an expertise in Pharmaceutical and Medical Device compliance issues. He performs GMP / Medical Device (QSR) and due diligence audits of manufacturing, packaging / labeling, laboratory and distribution operations for sterile / non-sterile drugs, APIs and medical devices. Andrei applies his experience to the evaluation and strengthening of Quality Systems, facilities/equipment, materials, production, laboratory and validation programs, systems and operations. He uses his proficiencies to develop, evaluate, monitor, and verify compliance of GMP/Medical Device (QSR) corrective action plans and enhance technology transfer and process/cleaning validation programs.

Expertise

• Provide leadership to QA/QC and compliance departments
• Perform gap analysis of quality systems, manufacturing, and laboratory systems
• Manage resource planning to ensure appropriate staffing, facilities, and equipment
• Establish contract manufacturers and implement quality systems
• Enhance quality systems for license reinstatement
• Act as project leader for start-up manufacturing of pharmaceutical, medical device, and biotech products
• Perform cGMP audits of API suppliers, contract manufacturers, and laboratories
• Monitor Regulatory Affairs Clinical submissions and sites
• Design and deliver training in cGMP / Medical Device (QSR) requirements and Quality Systems
• Oversee post-market stability trending, change control systems, and annual reviews
• Ensure appropriate quality policies are implemented and requirements met
• Manage resource planning to ensure appropriate staffing, facilities, and equipment
• Coordinate the testing of raw materials and finished drugs and advise clients regarding the quality and acceptance of manufactured and imported drugs
• Develop QA systems; monitor implementations of manufacturing systems
• Coordinate and audit NDA and ANDA submissions to FDA and HPB
• Conduct investigations to resolve product deviations

Professional Affiliations

• Vice President, Quality –  Merck KGA -Genpharm Inc.
• Director, QA / QC / Compliance – Novartis Pharmaceuticals Canada Inc.
• Manager QA Compliance – Novartis Pharmaceuticals Canada Inc.
• Director, Regulatory Compliance; Director, Regulatory Affairs; Manager, Regulatory Affairs for Canada – Genpharm Pharmaceuticals
• Senior GMP Drug Specialist / Compliance Investigator; Food and Drug Inspector – Government of Canada Health Protection Branch

Mr. Ronald Turton

Mr. Turton has been involved within the Health Canada and FDA regulated pharmaceutical industries continuously since 1971. His experience covers the areas of Research and Development, Quality Assurance, Quality Control, Compliance, Technical Services and all aspects of Validation from a senior Management perspective. Currently, Mr. Turton is the Chief Scientific Officer at Quality Compliance Laboratories (QCL) providing a wide range of analytical testing services to the pharmaceutical, bio-pharmaceutical, nutraceutical and related industries. Mr. Turton was instrumental in implementing most of QCL's quality systems including the stability storage and testing program.

Prior to QCL, Mr. Turton was associated with Patheon for five years overseeing a team of people responsible for Stability, LIMS, Instrument Validation and Calibration, Technical Writing, Sampling and Packaging Material Control and Annual Product Review (APR). This team was critical to the attainment of committed goals as their internal and external customers included personel and functions extending beyond the laboratory.

Mr. Turton began his career as a bench analyst with Adam's Brands in Toronto. Within a year, he'd transferred to their pharmaceutical division (Warner Lambert) where he worked in various laboratory departments before leaving to join Sandoz Pharmaceuticals where he progressed through laboratory Supervisor to various Management roles with ever increasing responsibilities. When Sandoz merged with CIBA to become Novartis Pharmaceuticals, one of Mr. Turton's duties was to facilitate the transfer of more than 50 product lines into the Whitby manufacturing site from the Dorval manufacturing site while maintaining product Compliance with no major disruptions in product supply.

Mr. Turton is a member of the editorial board of "Pharmaceutical Canada", the only Canadian magazine devoted to providing information specifically targeting the pharmaceutical industry. As well, he is the current chairman of the Research Ethics Board (REB) of Lakeridge Health Corporation overseeing ethical approval of clinical trials conducted at several sites affiliated with Lakeridge Health.

Mr. Turton is also affiliated with a number of pharmaceutical organizations such as: the International Pharmaceutical Academy, the American Chemical Society, the Chemical Institute of Canada and the Association of the Chemical Profession of Ontario. He obtained his Master of Science degree in Chemistry from York University, Toronto and his Bachelor of Technology in Chemical Technology from Ryerson University, Toronto, Ontario.

Mr. David W. Vincent
Senior Validation Associate

Mr. Vincent is the Chief Executive Office (CEO) of Validation Technologies Inc. CA – USA. He has over 23 years experience in the health care industry with 17 years in field of validation. Mr. Vincent expertise expands to many areas of Quality Assurance, Regulatory Affairs and Validation, including; eBLA submission preparation, facility and equipment design review, process development and validation, project management, and utility and process equipment qualification. He has been involved in the various aspects of bringing many new drug manufacturing facilities on-line, from design concept and engineering, through construction and start-up, to the qualification/validation, and licensing phases. He has presented many training seminars and written many articles regarding validation topics. Mr. Vincent teaches “Validation Program for Pharmaceutical, Biotechnology and Medical Device Industries “RA 776” at San Diego State University (SDSU) for their Regulatory Affairs Master Degree program. Mr. Vincent has a degree in Industrial Microbiology and Mechanical Engineering Technology. He has been consulting for many companies nationally and internationally.