Alacrita, which is changing the face of life science consulting, has established a powerful transatlantic Regulatory Affairs Practice to provide auditing, regulatory strategy and due diligence services to life science companies and investors. The Practice has been formed to help pharmaceutical, biotechnology and medtech clients overcome critical regulatory hurdles, devise effective regulatory strategies and provide on-going, hands-on regulatory support, including with regulatory applications. The team is also supporting companies and investors conducting regulatory due diligence.

The Practice currently comprises nine seasoned professionals, all of whom have their careers either working within regulatory agencies or shepherding life science products through regulatory processes. They have particular expertise in EU and US regulations and have many years’ experience of interacting with the competent authorities in these regions. The group has broad and deep technological experience, covering biologics, pharmaceuticals, generics, in vitro diagnostics and medical devices. By pooling their collective experiences and expertise, the group represents a formidable resource for any life science company needing to supplement its in-house regulatory capability.

Nick Higgins, corporate development director at Consort Medical plc and an Alacrita client said “Alacrita’s transatlantic team of experts was able to provide us with the specialist regulatory due diligence support we required. The advice was clear, well supported and enabled us to make an informed decision on a potentially complex issue.”

Professor Anthony Dayan, a member of Alacrita’s Advisory Board, expert in toxicology and Emeritus Professor of Toxicology at the University of London, said “Alacrita’s team has broad practical experience and deep knowledge of both the science and regulations, allowing it to effectively assess toxicological risk. It has the capacity and capability to work across a range of regulatory scenarios within the life science industries.”

“Each consultant has been selected on the basis of their track record of successfully applying creative solutions to critical regulatory issues” said Robert Johnson, Partner at Alacrita. “Given the group’s practical, hands-on experience, we go beyond just delivering GxP auditing services and, for example, actually help clients with dossier filings to FDA and EMA.”

Alacrita’s regulatory affairs expertise spans small molecules and biologics, sterile manufacturing, medtech and generics: small molecules and biologics whilst working in industry, Alacrita’s team took numerous pharma and biologic products from phase I through to marketing approval in both EU and US. Alacrita’s US biologics consultant spent eight years at FDA/CBER before moving into industry (Baxter, Medarex, Chiron) where she spent 20 years implementing innovative regulatory and quality strategies for timely product approvals.

Alacrita’s European team includes a Qualified Person who specializes in biologics, biotech products and sterile products. He has broad experience in the manufacture and control of both terminally sterilised and aseptically prepared sterile pharmaceuticals, including ophthalmic products, lyophilised products, and creams and lotions, as well as most non-sterile dosage forms. His US counterpart spent five years as a Microbiology Reviewer in the FDA’s Office of Generic Drugs and after a 35 year career is a highly qualified and well regarded problem solver of microbiology contamination issues.