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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Regulatory strategy and preparation for pre-IND meeting with the FDA

Challenge: A biotech company working in the microbiome space engaged Alacrita to provide advice about regulatory strategy and to prepare for and conduct a pre-IND meeting with the FDA. The product in...
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Biologics manufacturing support for a discovery stage microbiome company

Challenge: For a discovery stage microbiome company, Alacrita supplied a senior biologics manufacturing specialist to act as Interim VP CMC.
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Pre-IND meeting support for repurposed drug for stroke

Challenge: Our client was working with a family office which had invested in a novel IV formulation of a repurposed asset for the treatment of ischemic stroke. With a promising completed phase II...
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CMC and regulatory affairs gene therapy support

Challenge: A biotech company developing novel gene therapy approaches for in vivo cell trans-differentiation had lead programs in IND-enabling studies for two indications. The client requested...
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Regulatory assessment of a generic anti-diabetic peptide drug

Challenge: An established Alacrita client had developed a generic version of a major anti-diabetic peptide drug. It requested a report, based from a number of key questions posed by the client, on...
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Virtual Stewardship of a Targeted Cancer Therapy to an IND Submission

An early-stage biotech company developing a targeted cancer therapy engaged Alacrita to provide expertise to help them navigate an upcoming IND submission. An Alacrita partner and medical oncologist...
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Development & Refinement of a Patient-Reported Outcome (PRO) Strategy

Challenge: Alacrita was approached by a company developing an enzyme approved by the FDA for the treatment of toxic plasma chemotherapy concentrations in patients with delayed clearance due to...
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Documentation gap analysis in preparation for FDA scientific advice meeting

Challenge: Our client was committed to applying a deep understanding of axon regeneration and neuronal signaling pathways to transform the lives of patients afflicted with neurotrauma or...
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Supporting a CTA submission for the oral form of an approved biologic drug

Challenge: Our client was developing an oral form of an approved biologic drug which appeared to have excellent properties in terms of a rapid time to maximum concentration in the blood. A Phase II...
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Providing CTA submission support for a monoclonal antibody

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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Providing regulatory strategy for T-cell therapy

Challenge: Our client is a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies for serious diseases. The client wanted to understand whether...
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