Regulatory support to understand likelihood of approval of an ophthalmology asset

Challenge: A European pharmaceutical company focussed on ophthalmic care was seeking Well Established Use (WEU) approval in Europe for a small molecule asset. The company commissioned Alacrita to...
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Regulatory analysis of rejected marketing authorization & response strategy

Challenge: Our client, a major generics and biosimilars player, was developing a generic version of a major therapeutic. It had submitted a dossier for marketing authorization in the EU which was...
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Regulatory strategy for an ophthalmology product based on repurposing

Challenge: An ophthalmology specialty pharma company, for whom we had previously conducted due diligence, retained Alacrita to advise on the regulatory strategy for a new product based on repurposing...
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Preparing a EU Paediatric Investigators Plan

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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Applying for PRIME EMA status in the EU

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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Applying to Early Access to Medicines (EAMS) at the MHRA

Challenge: Our client was developing oncolytic viruses for treating a rare form of brain cancer. Its lead product had been successfully evaluated in a Phase I dose-escalation study. Direct injection...
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Regulatory strategy for a novel drug delivery technology

Challenge: Our client was developing a highly novel and versatile intracellular delivery vehicle which could readily penetrate cells without compromising membrane integrity or inducing cytotoxicity....
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Gap analysis for a CTA submission in the UK

Challenge: Our client was developing a novel iron treatment with potential to be best-in-class for iron deficiency anemia (IDA). The product used nanotechnology to mimic the natural structure of...
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Regulatory support in obtaining EU Orphan Drug Designation for a gene therapy

Challenge: Our client was a biotechnology company developing life-enhancing gene therapies designed to restore vision in patients suffering from blindness due to inherited retinal diseases. The...
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Gap analysis & pre-IND meeting preparation for preclinical compound

Challenge: Our client planning to develop and commercialize a preclinical compound for metabolic disorders. The product had a wide therapeutic potential for disorders associated with disruption of...
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Regulatory due diligence for A-Fib development drug

Challenge: Our client was a US-based venture capital fund, with whom we have a long-standing retainer agreement to provide specialized due diligence support for their fund investment decisions. In...
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Pharmaceutical Regulatory Affairs Case Studies

Alacrita's regulatory affairs consultants provide support to biotech, pharmaceutical and medtech clients, as well as companies and investors conducting regulatory due diligence. Our regulatory team...
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