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 regulatory submissions
- Global labeling development