Meet the Solara Team

Professional female that is the Owner and Principal Consultant for US and Canada Regulatory Affairs at Solara Regulatory Consulting.

Beryl St. Jeanne, MS, RAC-US

Owner and Principal Consultant, US and Canada Regulatory Affairs

I provide the strategic vision to guide my clients through complex regulatory processes and achieve your company’s ultimate goal of obtaining regulatory authorization. My strengths shine where product development has stalled or when negotiations with FDA raise more questions or roadblocks. Once on board, I become an actively engaged member of your team, executing strategy and turning your "Mission: Impossible" into "Mission: Accomplished".

I have 10 years of experience in the medtech and biotech industries. I have supported the full spectrum of medical device and combination products, including cardiovascular, combination products, dental, dermatology, ENT, gastroenterology, general and plastic surgery, pathology, neurology, OB/GYN, ophthalmology, orthopedics, radiology, respiratory, software, and urology products.

I hold a Master of Science degree in Regulatory Affairs and a graduate certificate in International Regulatory Affairs from St. Cloud State University. I also hold the credential of US-RAC certification and Medical Device certificate from the Regulatory Affairs Professionals Society (RAPS).

Professional female that is the Principal Consultant for Quality and EU and Rest-of-World Regulatory Affairs at Solara Regulatory Consulting.

Vesna Sevaljevic, MPharm

Principal Consultant, Quality and EU and ROW Regulatory Affairs

I provide exceptional leadership to navigate products through the regulatory and quality complexities of EU MDR and IVDR. I excel at facilitating timely market access and product compliance, reflecting my commitment to advancing healthcare standards.

I have over 20 years of experience in medical devices, IVDs, drug-device, and drug-diagnostic global regulatory affairs. This includes 12 years as a reviewer at the Serbian Competent Authority: Agency for Medicines and Medical Devices (ALIMS). I’m experienced in leading communication with Notified Bodies and Competent Authorities. Moreover, I develop and maintain Quality Management Systems and Risk Management documentation and execute internal audits.

I obtained the Master of Pharmacy degree from the University of Belgrade. I also hold the ISO 13485 Lead auditor certification through BSI.

Professional male that is the Senior Specialist for Regulatory Writing and Operations at Solara Regulatory Consulting.

Tyler Griggs

Senior Specialist, Regulatory Writing and Operations

I develop regulatory documents that communicate scientific evidence of medical product safety and efficacy to the FDA and other global health authorities, supporting product development, regulatory authorization submissions, and lifecycle management. I author clear and concise regulatory documents that withstand rigorous review from health authorities.

As a member of your team, I leverage my 20 years of professional writing experience to author scientific communications, systematic literature review, clinical trial applications, marketing submissions, and regulatory operations deliverables.

I earned the Bachelor of Arts degree in Science and Technical Writing with a minor in Journalism from the University of Wisconsin - Eau Claire. I also hold the Regulatory Writing certificate from the Regulatory Affairs Professionals Society (RAPS).