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 rejected due to failure to answer questions about fibrillation of amyloidogenic peptides. The company asked Alacrita to advise on the adequacy of its data package and response strategy for resubmission.
Solution:
Alacrita assembled a team comprising an ex-Agency consultant and a reserch scientist with expertisze in the types of assay in question. We analysed the data, highlighted the deficiencies and prosposed an appropriate program of work to generate sufficient information to underpin a successful resubmission.
Alacrita's Regulatory Affairs Expertise
Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path torward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing.