Scientific Advice Support

Early Regulatory Consultation to Increase Approval Success

In today’s competitive environment, it is more important than ever to ensure your product has a smooth progression through the early phases of development up to approval. Enlisting early consultative support to map your product’s ascent through drug development, clinical trials, and commercialization will ensure the most efficient and cost-effective path to success.

ProPharma Group is experienced in giving strategic regulatory guidance and independent advice, including assistance when preparing questions, briefing documents, and follow-ups of scientific advice meetings with EMA, FDA, and local authorities.  Our senior Regulatory Affairs professionals have the experience to get the most out of your meetings and can assist you with requests for Scientific Advice and/or MAA pre-submission advice. This advice may focus on issues related to:

  • Phase I/II/III clinical study design
  • The product itself
  • Legal
  • Regulatory
  • Logistics

The process surrounding Scientific Advice can also be fully outsourced including pre-meeting, briefing package, debriefing, analysis of the scientific outcome, and in some cases, being present at the meeting itself at local offices, FDA, or EMA.