Regulatory Affairs (3)

Challenge: Our client was a biotechnology company focused on use of a proprietary nanotechnology invented to allow different combinations of drugs to be encapsulated in a single nanomedicine and...

Challenge: Our client is an innovative, publicly-traded, lean biotechnology company focused on developing potential cures for infectious diseases and cancer utilizing cell therapies and proprietary...

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

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. Results were...

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 minimum...

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

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.

Challenge A medical device client needed help securing 510(k) clearance for a non-contact respiratory measurement device.

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...

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...

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...