About Us

pharmaceutical products covering everything from strategic development planning to market registration. Implementation of an appropriate regulatory strategy is critical to efficient drug development and the successful approval of products. RegCon Solutions provides expert consultation for development planning, agency advice, and regulatory submission strategy.
We understand all of our clients are not the same and will tailor the services we provide to your specific needs. As industry leaders, we are able to provide guidance and assistance in the following areas:

·Writing the CMC and summary sections of an application
·Publishing submissions in the eCTD format
·Reviewing submissions for compliance with current Agency expectations in mind
·Reviewing of technical documents to ensure things are done correctly the first time
·Providing regulatory strategy
·Assisting with Agency meetings

Contact us today to find out exactly how RegCon Solutions can help you!

At RegCon Solutions, LLC, we take a unique approach to working with our clients. We see ourselves as an
extension of your team and take ownership of the projects we work on as opposed to the traditional consultant-client relationship. We strive to provide true customer service and have an unparalleled record of achieving project timelines.
Keeping up with ever changing regulations is a full time
job. Let us take care of that for you. We have significant experience in helping clients understand the regulatory requirements for the development of