Product Development (9)

Alzheimer's due diligence Our client, a major pension fund, was considering an investment opportunity in a Phase III neuroscience company. The company was developing a small molecule to provide...

Alacrita's 510(k) regulatory affairs consultant worked with our UK medical device client to secure 510(k) clearance to for a non-contact respiratory measurement device. She provided strategic...

Oncology Scientific Advisory Board An emerging drug discovery company, with a core expertise in molecular modelling, had developed a small molecule inhibitor of a novel cancer metabolism target. The...

A leading research institute developing novel approaches for production of ophthalmic treatments asked Alacrita to conduct a market and competitive assessment of the current supplier base and...

A university research team had worked for a number of years on the development of a novel interventional cardiology device. Recent progress had been made with pre-clinical testing on pigs, as well as...

10111A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care, and has mapped regulatory pathways that pertained to various classes of product. Having...

Drawing on expertise from its regulatory, gene therapy and manufacturing consultants, Alacrita conducted feasibility study and formulated a business case for a new GMP facility for production of...

Challenge: Anti-nerve growth factor inhibitors are a new class of powerful analgesics in clinical development. They were put on clinical development hold by the FDA in 2012 due to joint-related...

Alacrita's consulting team supports a number of pharmaceutical & biotech companies with medical and clinical strategy. We have particular depth in oncology, but also have expertise in infectious...

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 to...

A venture-backed biotech company, developing a clinical stage asset for the treatment of early stage cancer, was populating a dataroom and preparing for negotiations with a major pharmaceutical...

Alacrita Consulting's founders worked together for over 10 years at Onyvax, a London-based cancer immunotherapy company backed by SR One. We have conducted a number of consulting projects in the...