SCIENTIFIC RESEARCH ORGANIZATION REINVENTED

President/CEO

Christina has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. She has assisted foreign health departments in writing legislation and working with clients in over 60 countries with licensures and permitting. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.

Sr Director of Product & Process Development

Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development, RA/QA, EU-MDR/IVDR, QbD, and CSV-GAMP-Part11. Bill has  successfully characterized and taken scores of medical devices, Biotech, Pharma, and Combo Products, Designs, Materials, & Processes from concept through commercialization via QbD, Design Controls, Risk, PMS, CER, PRRC, data trending, submissions, site inspections, turnarounds, and all intermediate functions. He is a recognized international & domestic invitational Biotech, medical device, Combo, CSV, and regulated life science leader, presenter, assessor, remediator, instructor, implementor, and author. Those who have and do work with Bill, continually nickname him “Doctor Bill” for his passion, skills, integrity, and compassion in effectively aligning and harmonizing people and organizations within the regulated life science Industry. Bill’s Regulated Life Sciences background includes, but not limited to, Management, Leadership, and Director Levels for J&J Medical Devices, Biotech, Stem Cells, IVDs; turnaround of Carefusion, and IVD Submissions Serono-Baker, respectively. These experiences span several decades, multiple continents, numerous International Regulatory Bodies. His Medical Device Design Control expertise has its roots in his nearly five years of Software Design and Development and Controls. To-date Bill has led and guided >4000 professionals, across multiple global Sites, in Design Controls, CSV, Part 11 GAMP & QbD, and 1000s of professionals as an Invitational Presenter at numerous Professional Conferences, and 1000s more via publications and ISPE Guide Series.

Regulatory Expert

Dallas L. Thomas, RAC, MHA, MPA has 14 years’ experience in the medical device industry in the areas of regulatory affairs, quality management systems, compliance, auditing, and clinical evaluation. Dallas works on activities associated with FDA submissions, particularly 510(k), Emergency Use Authorizations, FDA Enforcement Policies, FDA Establishment Registration, UDI, GUDID, CE Marking per EU MDR 2017/745 maintaining regulatory approvals, compliance to ISO 13485:2016, MDSAP Audits, Internal Audits, Gap Audits, Supplier Audits, FDA regulatory and quality support, and European regulations among other international market authorizations of products, and clinical evaluation reports (CERs). His qualifications include Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society, Certified Lead Auditor for ISO 13485 issued by BSI, and is a Six Sigma Yellow Belt. He also brings his education to our team with a Bachelor’s in Human Development, Masters’ of Healthcare Administration, and Masters of Public Administration. He has experience working with multi-disciplinary teams supporting product development and product sustaining. Dallas also brings exposure to national & international regulatory standards such as the new EU Medical Device Regulation (MDR), Good Manufacturing Practices (GMPs), ISO 13485, ISO 9001, Quality Systems Regulation (QSR), 21 CFR part 820, Food Drug and Cosmetics Act, RDC 185 (ANVISA in Brazil), MDD 93/42/EEC, and Latin America regulations among others. Dallas also bring his multilingual skills to our team, as he is fluent in Portuguese and Spanish, and has lived abroad in Latin America in the past.

VP of Global Business Development

For more than 20 years, Michael has developed innovative solutions for customers across the globe. He has negotiated agreements with governmental authorities in the Middle East, Asia, Africa, Europe and the Caribbean to insure his clients are able to transact business in the US with seamless integration. In his role at Biotech Research Group, Michael provides synergistic approaches for international and domestic customers to create efficient solutions for regulatory, legal, and developmental needs.