News & Insights
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…
Data Integrity and the Pre-Approval Inspection: An Inspector’s Experience
Overview Data integrity has always played an essential role in regulatory application review and cGMP inspections – a trend that will only continue to grow in the coming years. The FDA's April 2016 draft guidance document "Data Integrity and Compliance with cGMP" is an important step by the Agency…
Biologics Consulting Continues to Expand with the Addition of Three New Team Members
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today the addition of three new consultants, further increasing the company's capacity to deliver comprehensive scientific, technical and strategic guidance…
Zika Virus: The Development of Medical Countermeasures
Overview The global concern about Zika virus continues to grow as the international community braces for its continued spread. There is currently no vaccine for the virus. However, the increasing evidence of vertical transmission, teratogenic effects and potentially severe complications such as GBS has…
Biologics Consulting Expands Services, Launches Clinical Trials Planning and Oversight Group
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announces the launch of its Clinical Trials Planning and Oversight Group. The group will help small and medium-sized biopharmaceutical companies in the development…
Clinical and Regulatory Considerations for Orphan Drug Applications
Overview The development of Orphan Drugs - those developed specifically to treat rare medical conditions - is growing at an astounding rate. In 2014, nearly 41%1 of all new product approvals from the FDA were for the treatment of rare diseases - a trend that is expected to continue as the exclusivity…