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
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.
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.
Related Case Studies
Conducting ISO 13485 audits
A blue-chip healthcare consumer products company needed a medical device consultant to conduct an ISO 13485 audit of the mainland Europe manufacturing site of a potential supplier company....
Regulatory Affairs: BLA submission support
Background Alacrita`s client was nearing the completion of a pivotal Phase III with a novel antibody-based therapeutic. The product was designed to delay recurrence in cancer patients with minimum...
Due diligence – regulatory affairs
To help a clinical stage biopharmaceutical specialist company in its regulatory due diligence activities, Alacrita assembled an expert team comprising an ex-quality assessor who had previously worked in the...
Supporting BLA submissions
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...
Medical Device Consulting
Medical device 510(k) submission strategy Alacrita’s client had successfully CE marked a novel lung function device, and the next step in the commercial strategy was to obtain 510(k) clearance...
ISO13485 Audit by medical device consultant
Alacrita was asked by a blue chip healthcare consumer products company to provide a medical device consultant to conduct an ISO13485 audit of the mainland Europe manufacturing site of...