Drugs and Cosmetics
Expert FDA Compliance Support for Drugs, Antiseptics, and Cosmetics
Our team has substantial knowledge of FDA regulations to support you with testing, marketing material reviews, compliance, and proper listing of over-the-counter drugs, antiseptics, hand sanitizers, and cosmetics. Many of SRC’s team members have over 30 years of experience working with over-the-counter drugs as well as antiseptic product manufacturing and testing facilities.
We frequently partner with our clients on GMP books and records audits, registering facilities and listing products in CDER and Cosmetics Direct Portals, data generation and review, and troubleshooting the testing and manufacturing processes. Our lengthy historical knowledge of FDA processes gives us a unique edge when assisting you with all of your drug and cosmetic product compliance needs.
Schedule a consultationSupporting a Wide Range of Regulated Product Types
Our expertise spans multiple product categories, giving you confidence in compliance no matter what you manufacture or market.
How we guide you to success
From expert guidance to tailored solutions, our team is here to help you navigate every step of the regulatory process with confidence.
Schedule Consultation-
Knowledge
We have an extensive background in FDA over-the-counter drug and antiseptic regulations and have closely followed the newer cosmetics regulations throughout their development. With a comprehensive understanding of the laws and requirements, we are able to help your team with all of your product development, marketing and stewardship questions.
-
Training
Are you seeking to grow and develop your team’s regulatory knowledge? Our team members have provided dozens of high-quality training presentations for national industry meetings and international webinars. In light of our background and experience, we are a great choice to provide in-depth training and webinar programs.
-
Experience
We have worked with and collaborated in the development of hundreds of products, which enables our team to provide guidance on most regulatory issues or questions that may arise throughout the testing and registration process. Partner with SRC and be confident you are achieving and maintaining proper compliance with your product.
-
Manufacturing
We have team members who have managed, audited, and worked in GMP manufacturing facilities, which allows us to guide clients as they set up and audit GMP processes and facilities. We also use this expertise to advise our partners on proper handling of any issues that may arise during the manufacturing and distribution process to minimize the cost and risk associated with errors.
What’s new in regulatory affairs
Our regulatory consultants keep you informed with the latest insights and updates.
