News & Insights
Biologics Consulting Expands Management Team with the Addition of Kenneth P. Guito, MBA as Chief Operating Officer
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that Kenneth P. Guito, MBA was hired as its Chief Operating Officer (COO) following a 35-year career in the Biotech/Biopharmaceutical Industry. Mr…
Biocompatibility Nuances And Its Impact On Medical Devices
Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority…
Understanding the CDRH Reorganization and Its Potential Impact on Premarket Submission Reviews: Frequently Asked Questions & What You Need to Know
Overview It can be hard to keep up with the rapid pace of changes in FDA's regulations and review policies for medical devices. One area that changes roughly every 5 years in some capacity is the organizational structure of the Center for Devices and Radiological Health (CDRH). However, the new reorganization…
Biologics Consulting Bolsters Medical Device Regulatory Services with the Addition of Four New Consultants
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…
Regulatory Strategy for Pre-IND Meetings with FDA: Why Meet & What to Ask
Overview For those developing a new biologic or pharmaceutical product, Pre-Investigational New Drug Application (pre-IND, PIND) meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors…
Medical Device De Novo Classification Applications: Frequently Asked Questions and What You Need to Know.
Overview In recent years, the FDA has overhauled the De Novo program to make it simpler and more attractive to medical device manufacturers. This increased emphasis has resulted in an accelerated rate of change in the Agency's regulations, processes and procedures, including the recent guidance document…
Biologics Consulting Expands Pharmacology-Toxicology Expertise; Adds Two Senior Consultants To Growing Team
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today the expansion of its Pharmacology-Toxicology team with the addition of two new senior consultants with more than two decades of combined experience…
Biologics Consulting Assists BriaCell Therapeutics In Gaining FDA Clearance To Initiate A Phase I/IIa Clinical Trial Of BriaVax™
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that its Chemistry, Manufacturing, and Controls (CMC) Specialty Group advised BriaCell Therapeutics Corp. (TSXV: BCT) (OCTCQB: BCTXF), a clinical-stage…
IDRI Expands Board of Directors with Former FDA Leader Norman Baylor
IDRI (Infectious Disease Research Institute) is expanding its Board of Directors, comprised of international leaders in industry and academia, with the recent addition of Norman Baylor, Ph.D., who has extensive experience in the field of vaccines and vaccine-related products, including 20 years with…
Biologics Consulting Expands Footprint, Opens New Office in Maryland’s Technology Corridor
Biologics Consulting, a full-service regulatory and product development consulting firm focused on the life sciences industry, announced today that it is opening a new office in the center of Maryland's Technology Corridor and Life Sciences Hub. The new office is located in Rockville, Maryland and will…