Regulatory Strategies for Small and Medium Companies

Date: March 14, 2025
Time: 12 PM EST
Duration: 60 Minutes

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:

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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.