Scientific and Strategic Consulting
Regxia offers strategic and innovative advice throughout the entire development process. Our integrated and innovative approach ensures an efficient and planned development cycle and a seamless transition to market and throughout its lifecycle.
1
Gap Analysis of Dossiers and Responses
Regxia is able to assess dossiers for strengths and weaknesses, regulatory authority acceptance and corrective measures. Regxia’s extensive experience creating and adapting submissions for new jurisdictions allows us to identify potential questions from regulatory agencies during assessment and, most importantly, pro-actively develop resolutions.
2
Support for Agency Meetings
Regxia has experience working with Canadian and international regulatory agencies. On behalf of our customers, Regxia has arranged for timely meetings, prepared high-quality and effective briefing documents and provided advice on presentation content and format. Regxia’s excellent relationship with the agencies has allowed us to expedite and facilitate successful resolutions to agency questions and issues.
3
Literature Reviews to support SRTD or 505(b)(2) Applications
Regxia’s team is experienced in conducting systematic literature reviews in alignment with the methodology prescribed in the Cochrane Handbook for Systematic Reviews of Interventions.