Appealing FDA refusal of an orphan drug designation application

Challenge: A biopharmaceutical company was seeking assistance to prepare a response to the FDA’s initial refusal of its orphan drug designation application for its novel CAR-T therapy intended for...
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Regulatory plan for a biotech with proprietary nanotechnology

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...
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Cell therapy CMC regulatory affairs & pharmacology & toxicology support

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...
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MHRA scientific advice for a UK PhII trial in PSC

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...
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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. Results were...
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BLA submission support for a novel antibody-based therapeutic

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...
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Regulatory due diligence

Challenge A clinical stage biopharmaceutical specialist needed support with its regulatory due diligence activities.
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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.
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Submitting 510(k) applications

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

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...
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510(k) consulting for respiratory medical device

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...
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Wound care - regulatory support

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...
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