Regulatory and quality
Alacrita’s transatlantic Regulatory Affairs Practice provides auditing, regulatory strategy and due diligence services to life science companies and investors. The Practice, which includes five QPs, 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.
All members of the practice are seasoned industry executives who have spent 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, API, 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.
Orphan Drug Designations
Alacrita provides consulting support for US and EU Orphan Drug designation filing. Our lead European regulatory affairs consultant has been involved, with variable intensity, in approximately 140+ orphan products. As a consultant he has advised a number of companies regarding their orphan designation procedures. He is currently supporting 3 US companies (2 granted, 1 ongoing), 2 Japanese companies (2 granted) and 4 European companies (1 granted, 3 ongoing).
Our experience of EU orphan drug designation spans many therapeutic areas, including oncology, immunology, CNS (Parkinson) and congenital enzyme deficit leading to serious metabolic disease.
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.
Alacrita’s medtech regulatory specialists have deep experience in the development, manufacturing, quality systems and regulatory affairs of medical devices and in vitro diagnostics. In medical devices, Alacrita’s consultant has acted as a senior representative for several well-known Quality Certification Bodies (Notified Bodies) implementing consulting, training and auditing assignments worldwide. His diagnostics colleague has over ten years tenure as Head of a Medical and IVD Notified Body, having secured the first IVD Notified Body status in the UK for Underwriters Laboratories Inc. To date, they have completed over 300 medical device and in vitro diagnostics audits.
Generics and Biosimilars
Alacrita’s generics consultant has over 15 years’ experience in pharmaceutical regulatory affairs, pharmacovigilance and as a pharmacist. She has extensive experience in generic pharmaceuticals where she has been responsible for both strategic management and operational implementation. She also works on projects involving pharmaceuticals, medical devices and herbal medicines for a client base in the EU, USA and Canada.