BIOLOGICS CONSULTING BOLSTERS MEDICAL DEVICE REGULATORY SERVICES WITH THE ADDITION OF FOUR NEW CONSULTANTS

BIOLOGICS CONSULTING BOLSTERS MEDICAL DEVICE REGULATORY SERVICES WITH THE ADDITION OF FOUR NEW CONSULTANTS

Alexandria, Virginia - September 12, 2018

Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today its acquisition of new talent to bolster its Medical Device Specialty Group and support the growing demand for medical device regulatory and product development support.

Christy Foreman, MBE, Lisa Graney, RAC and Sam Mostafavi, MS, MBA join Biologics Consulting as Senior Consultants and Joshua Crist, MSE, as a Consultant, bringing over 70 years of combined experience to the Medical Device Specialty Group. Foreman, Graney, Mostafavi and Crist will advise a variety of clients on regulatory strategy and design control for devices, prepare submissions such as RFDs, Pre-IDEs, IRBs, IDEs, HDEs, 510(k)s, PMAs, among others, and provide training in best practices for risk management, clinical evaluation, advertising and promotion review, management of external standards, among other regulatory requirements and processes. The addition of these consultants and their Industry and Agency experience will further Biologics Consulting’s expertise to provide unparalleled insider perspective to its medical device clients.

“Our strong team of experts is the backbone of our success – allowing us to deliver innovative solutions and real results to our clients,” commented Norman Baylor, PhD, President of Biologics Consulting. “The addition of these new team members further underscores our commitment to improving public health and bringing life-changing devices to market. We look forward to seeing the results of their work and expertise as they guide our clients through the regulatory process.”

Christy Foreman, MBE, joins the team with over 28 years of federal government experience with 22 years at the FDA, where she held numerous positions in both the premarket review program and the compliance programs for medical devices. Previously, Foreman was the Director of the Office of Device Evaluation in the Center for Devices and Radiological Health, where she oversaw the premarket review of all non-IVD medical devices, and she also served as the Deputy Division Director for the enforcement division responsible for cardiovascular, neurology, orthopedic, physical medicine anesthesiology and radiology devices in the Office of Compliance. She has extensive experience with premarket regulatory programs (PMAs, 510(k)s, de novo applications, IDEs and pre-submissions) and well as good manufacturing practices including the Quality System Regulation and postmarket enforcement issues such as recalls, warning letters, seizures and injunctions for a wide variety of medical devices.  With her background, she will provide expert regulatory and quality consulting services for a wide range of medical devices.

Lisa Graney, RAC, brings 25 years of experience in regulatory affairs and quality management systems for medical device companies to Biologics Consulting, including orthopedics, ophthalmics, IVD’s, imaging anesthesiology, and regenerative medicine (tissues and cells). Prior to joining Biologics Consulting, Graney served as the Vice President of Global Regulatory & Clinical Affairs at LifeNet Health and was the Worldwide Vice President of Regulatory Affairs at Johnson & Johnson. Graney has extensive experience working with a wide spectrum of medical devices and her experience with medical device regulations outside of the U.S. allows Biologics Consulting to offer OUS medical device regulatory services to current and new clients. In her new role as Senior Consultant at Biologics Consulting, she will utilize her Regulatory/Quality expertise to provide optimum support to national and international clients.

Sam Mostafavi, MS, MBA joins the team with over 20 years of experience in medical device regulatory and quality assurance. Prior to Biologics Consulting, Mostafavi served Conavi Medical as Head of Quality and Regulatory responsible for implementing a quality management system. He has extensive experience with quality management and regulatory compliance programs, and has planned, implemented and obtained ISO 13485, CMDCAS, CE Mark, and PMDA clearance. He also has direct experience in product and software development lifecycle from concept to commercialization, including design development, regulatory strategy, authoring of regulatory submissions, study planning, quality system, manufacturing, and post market surveillance. Additionally, Mostafavi has experience in international regulatory approval and production setup and qualification. At Biologics Consulting, he will provide a range of regulatory and quality services to address US and OUS regulatory needs.

Joshua Crist, MSE, joined Biologics Consulting in 2018 with seven years of experience as a biomedical engineer and lead reviewer at the FDA in the Office of Device Evaluation (ODE), Division of Surgical Devices (DSD), where he evaluated a wide variety of device and submission types. His experience includes review of IDEs, 510k(s), De Novos, PMAs, HDEs, Q-Submissions (Pre-Submissions), and Expedited Access Pathway (EAP) submissions. Crist’s strong technical skills in materials science, as well as his extensive experience reviewing a range of medical device submission types, will allow him to provide expert advice to clients on both the scientific and regulatory strategy aspects of premarket submissions.

 

About Biologics Consulting (www.biologicsconsulting.com/)

Biologics Consulting Group, Inc. is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices. Founded in 1993, Biologics Consulting has built a record of achievement, assisting clients worldwide with nonclinical and clinical, product development and regulatory compliance challenges.

Biologics Consulting has served more than 4,100 companies in 58 countries and has contributed to more than 750+ Pre-INDs/INDs, 170+ BLAs/NDAs/ANDAs, 210+ 510(k)s, and 50+ IDEs.