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, 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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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 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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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.
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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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AAV Gene Therapy Consulting

Assessment of an AAV gene therapy for an opthalmic indication Alacrita conducted an assessment of an AAV gene therapy for an ophthalmic indication, focusing on market potential, technical and...
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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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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...
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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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