Webinars >>Regulatory Strategies
Regulatory Strategies for Small and Medium Companies
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Optimum regulatory strategy is the compromise between what’s needed per the regulations and what’s practically feasible at a given time-point in the life of a proposed product. Small- and medium-sized enterprises (SMEs) often struggle to define “suitable” regulatory strategies for their products. Compared to conventional regulatory affairs groups at large pharmaceutical and device companies, small companies are known for having employees wear multiple hats and depend on external consultants for advice. It is neither required nor practical to do everything in the book like a large company but how does one gets to decide what needs to be done now and what can be deferred to a later time. Companies need to establish achievable milestones and put all resources to get to the same. With the regulatory requirements changing rapidly, and incentives and opportunities shifting constantly, and multiple incentives for developing promising products underutilized by SMEs, companies need to find creative ways for regulatory intelligence and adaptive strategies. Limited resources, lack of experienced personnel in all areas of need, and the resulting deficiencies in regulatory and development strategies are the key reasons for the high failure rate (more than 90%) of small- and medium-sized enterprises (SMEs). The regulatory strategy should be integral and continuous. This seminar will discuss approaches for regulatory strategies that make sense for SMEs. Further these approaches can be useful even to large organizations in finding ways to increase efficiency and maximize returns.
Areas Covered in the Session:
  • Basic elements of regulatory intelligence for SMEs
  • Role of free and public versus paid and non-public information in regulatory strategy
  • Making the most of the regulatory support available to SMEs from FDA
  • Three steps to an adaptive regulatory strategy
  • Best practices for building a hybrid regulatory team using internal and external personnel
  • Optimizing, prioritizing, organizing regulatory strategy documents
Why should you attend:
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This webinar, presenting by a SME expert will discuss how SMEs and Start-ups can develop competitive regulatory programs in a resource-limited environment. Using examples and cases studies, factors that determine replication of previous strategies, or creation of new development pathways will be discussed. The seminar will highlight key strategies to maintain high quality proactive regulatory intelligence, dos and don’ts, common areas of concern, and trouble-shooting practices. The pros and cons of the “follow-the-leader” approach, and investing in new ways of working will be discussed. These innovative business approaches are also useful for established organizations to create lean, adaptive regulatory affairs teams.
Who will benefit:

This webinar will provide valuable assistance to: 
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: December 9, 2020
​Duration: ​60 Minutes
​Time: 12PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com