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 a well-known active ingredient.
Solution:
Alacrita reviewed the project documentation to assess whether the well-established use (WEU) route would be a feasible pathway to registration. We then helped compile a briefing document and and supported the client through scientific advice with the relevant regulatory authorities.
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.
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