Pharma regulatory consulting

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 ongoing, hands-on regulatory support, including assistance 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. 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.

Case study: European wound care regulatory strategy

Challenge

A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care, and had mapped regulatory pathways relating to various classes of product.

Having identified various paradigms for currently marketed products in the US, including 510(k), Class III PMA, banked human tissue, Biologics License Application, and New Drug Application, the company needed to understand the corresponding regulatory pathways in Europe, and the regulatory requirements for bringing three of its products to market.

Solution

For this project, we handpicked a regulatory wound care specialist consultant (who was previously an MHRA assessor) to conduct this project. The final output included:

  • descriptions of the considerations used to classify each product into the appropriate regulatory class
  • risks and uncertainties in such classification and how these may evolve over time
  • data and documentation requirements likely to be needed for licensure

Further regulatory affairs case studies, performed by Alacrita’s regulatory consultants, are available here.

Case Studies

MHRA scientific advice for a UK PhII trial in Primary Sclerosing Cholangitis

Challenge Our client specialised in the development of proprietary monoclonal antibodies directed towards novel targets for the treatment of immune-mediated and fibrotic disorders,...

Advice for regulatory approval of a new Ancestral DNA device

Challenge Our client offered a genetic ancestry test in the form of a home kit that contained a buccal swab to collect customer DNA and an analysis service using a SNP array-based chip....

Supporting BLA submissions

Challenge Our client was nearing the completion of a pivotal Phase III trial with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with...

Regulatory due diligence

Challenge A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.

Supporting medical device 510(k) submissions

Challenge A company had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance to market in the USA.

European wound care regulatory strategy

Challenge A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care, and had mapped regulatory pathways relating to various classes of product.