News & Insights
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 The FDA's April 2016 draft guidance document "Data Integrity and Compliance with cGMP" is an important step by the Agency…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…
Biologics Consulting Unveils New Brand Identity; Launches Expert Edge Webinar Series Providing Participants Access to Top Consultants
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, has launched a rebranding effort that includes the introduction of new brand positioning, as well as a new logo and interactive website. In conjunction with the…
The Value of Analytics for Achieving Successful Manufacturing Process Transfer
Overview The biopharmaceutical product development lifecycle often requires the transfer of a manufacturing process from one facility to another. These transfers can occur at any point along the development path, and may be driven by increases in material needs to support clinical studies or the commercial…