Pharmaceutical Regulatory Affairs Consulting

Alacrita’s regulatory affairs team provides auditing, regulatory strategy and due diligence services to life science companies and investors. We help our pharmaceutical, biotechnology and medtech clients overcome critical regulatory hurdles, devise effective regulatory strategies and provide ongoing, hands-on regulatory support, including assistance with regulatory applications. The team also supports 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. Alacrita’s consultants have particular expertise in EU and US regulations and have many years’ experience of interacting with competent authorities in these regions.

The group has deep preclinical and clinical technological experience covering biologics, pharmaceuticals, API and generics. By pooling our collective experiences and expertise, the team represents a formidable resource for any life science company needing to supplement its in-house regulatory capability.

Featured Case study: Cell and Gene Therapy Regulatory Support

Challenge:

Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell and gene therapies and proprietary platform technologies. The primary infectious disease target is Human Immunodeficiency Virus (HIV). There are numerous cancer targets, focused on hard-to-treat solid tumor indications where, currently, Chimeric Antigen Receptor (CAR) technologies have faced numerous challenges. 

Alacrita was engaged to provide cell and gene therapy regulatory affairs consultant support for Chemistry, Manufacturing & Controls (CMC), and Pharmacology & Toxicology to help support and accelerate client Research & Development (R&D) activities.​

Solution:

Alacrita's cell and gene therapy regulatory affairs lead consultant has over fifteen years' experience working in this field, both with the FDA as a senior regulatory specialist and subsequently within the pharmaceutical industry developing novel cell therapies. Our regulatory affairs team worked with the client to develop a regulatory strategy for its lead cell therapy product, as well as additional products in the pipeline. 

Other members of our consulting team were then integrated into the client R&D Team and their external contract organizations to ensure a smooth implementation and oversight of the strategy. For the lead drug, Alacrita's regulatory affairs expert supported the client with the management of contract manufacturing organization relationships, strategic support and implementation of manufacturing process and analytical method development and optimization, strategic support and implementation of Investigational New Drug (IND)-enabling in vitro and animal studies, as a regulatory liaison for first-in-human clinical trial design and associated information client education on FDA requirements, meetings/interactions and submissions for cell and gene therapies​.