ISO 9001:2015   |   ISO 27001:2013

Regulatory Strategy

The cornerstone of any successful drug development program is a robust regulatory strategy. MMS offers experienced guidance and creative global strategies that allow a sponsor to effectively negotiate and navigate through the regulatory hurdles that arise during drug development and create a path forward.

Our worldwide regulatory experience spans multiple therapeutic areas, all major agencies and most smaller markets. Our in-depth awareness of the factors which influence the external environment enable us to present a comprehensive, efficient and successful regulatory pathway. This enables our sponsors to build trust and collaboration with various regulatory agencies.

Some of the services we offer are:

  • Provide guidance and support to new and ongoing development programs that balance the overall strategic objectives of the organization with the global regulatory requirements
  • Create proactive or reactive regulatory strategies to respond to anticipated or unforeseen regulatory hurdles
  • Planning and preparing for successful agency meetings
  • Planning and creating global submissions
  • Global labeling development

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!