Our Team
Glen Feye, MS CQE – President of Accurate Consultants
Lead in the development and implementation of strategic regulatory plans for clients in the FDA regulated industries and provide liaison support with regulatory authorities. With over 30 years of MedTech experience in Regulatory and Clinical, Quality Assurance, Design and Risk Controls, and FDA Compliance Glen offers strategic quality and regulatory guidance and information.
Prior medical experiences include: 513g, Pre-Submissions, Premarket Notification (510k), IDE Submissions, PMA and PMA Supplements
Education: MS in Pathology University of Mississippi Medical Center – Specialized in Immunopathology, BS in Biology Gettysburg College PA, CQE – Certified Quality Engineer (ASQ)
Dilip Ashtekar, Ph.D.
A result oriented collaborative leader with over 33 years of successful proven record of handling increasing responsibilities in leading Pharmaceutical, Biotechnology, Cell therapy, and Vaccine companies such as Intarcia Therapeutics, PAREXEL International, Gilead Sciences, Amgen Inc., AstraZeneca-MedImmune, Watson-Schein, Advance Tissue Sciences, Teva Pharma-Gensia Sicore, Chesapeake Biologics and CIBA‑GEIGY. Recognized as a proactive leader in anticipating, troubleshooting, resolving quality and regulatory issues, improving productivity and building high performance teams.
An acknowledged industry expert in the following Areas
1. Microbiology, aseptic processing, contamination control programs, visible particle control for parenteral products and Devices, visual Inspection processes for parenteral drugs, compliance audits and building quality culture.
2. Data Integrity compliance and sterility assurance for the aseptic manufacturing of drug substance and sterile drug product (small molecules, therapeutic monoclonal antibody vaccines and proteins).
3.Extensive experience with sterile Medical Devices Combination Products.
4. Aseptic manufacturing facility validation conventional ISO5 cleanroom, Isolators and RABS.
Mario Gemar, Ph.D.
Experienced regulatory and quality based professional, working in the Medical Device, In-Vitro Diagnostic and Pharmaceutical Industries for over twenty years. His core expertise is in the Regulatory Requirements and Quality Management System, including Design Control, Process validation, Tests Methods Validation, Management experience in sterilization technologies and their validations clinical investigations/evaluation, PMCF in compliance with MDCG, ICH GCP and FDA guidelines and audits at sites of investigational products, clinical analysis labs. In addition, he has specific expertise in R&D and quality requirements for Medical Devices, Diagnostics and Combination products. This has included the writing, implementation and maintenance of Quality systems, auditing of external suppliers and manufacturing/distribution sites and due diligence auditing. He also has extensive experience in the application of Design Control and post market surveillance systems for Complaints Management and Vigilance Reporting, Process Validation, CAPA, risk management and Clinical studies.
Location: Modena – Italy
Sebastian Feye, RAC Global – Devices
Sebastian is a Regulatory Affairs specialist and project manager for both medical device, IVD and drug projects. He communicates directly with FDA and serves as the liaison between clients and FDA. Sebastian has prepared and submitted successful EUA, Pre-Submissions, 510(k), PMA Annual Reports and PMA Supplements submissions for development of new medical devices. Sebastian also serves as project manager for various non-compliance projects, including 483 and Warning letter remediation projects, Additionally, he manages FDA device and drug registration and listing for both domestic and international clients.
Curt Wichtern – MedDev Software Consultant
Curt is a highly motivated software leader with over twenty-five years of experience with fifteen of those years in medical devices. Built several successful technical teams to solve difficult problems. Uses his knowledge of industry best practices to strategically apply design controls, development methodologies, and regulatory standards. Knows a variety of programming languages, frameworks, and databases. Seeking interesting problems to solve.
