Regulatory Affairs

Challenge: An early-stage biotechnology startup company reached out to Alacrita for critical support of its two lead AAV-delivered gene therapy programs. As a virtual company, the client needed...

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...

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...

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...

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...

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...

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....

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...

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...

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...

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...

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...