CMC can make or break a CGT approval, as DHC’s experts know well. Time spent on getting CMC development right will nearly always pay dividends by streamlining next steps towards regulatory approval and commercialization.
Dark Horse is uniquely positioned to provide both strategic and tactical regulatory assistance to our clients for their global regulatory needs. We are connected with current and former staffers of multiple worldwide regulatory bodies and have supported filings for clients across a wide range of global jurisdictions and stages of development.