FDA Registration
Decades of FDA Regulatory Expertise for Antiseptics, Hand Sanitizers, and Cosmetics
Many of SRC’s team members began their careers working with hand sanitizer and antiseptic products. Our team has continued to expand our 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. We have over 30 years of experience in books and records and GMP requirements, which makes us a great fit to assist you with auditing, registering in CDER and Cosmetics Direct Portals, and troubleshooting your manufacturing processes. Our lengthy historical knowledge of FDA processes gives us a unique edge when assisting you with FDA facility inspections and findings.
We also have specialists in MoCRA regulation for cosmetic products. We are monitoring the guidelines and requirements for this new regulation and ensuring our clients are aware of and meet each compliance deadline. We are happy to review labels, file product listings, and facility registrations in Cosmetics Direct, and help you with safety substantiation and Good Manufacturing Practices.
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Did you know?
The FDA has adopted the CDER Direct program to streamline annual certifications and drug listings.
Supporting 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.
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History
Many of our team members, including SRC’s founders, began their careers working at antimicrobial drug and biocide manufacturers and testing facilities. We have team members that have been working with FDA registered products since the development of the 1994 Tentative Final Monograph for Healthcare Antiseptic Drug Products and 1991 Tentative Final Monograph for First Aid Antiseptic Drug Products. We combine our full history on the monographs with our involvement in current ingredient reviews and regulation updates to set your product up for long-term success.
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Knowledge
Our team consists of regulatory professionals and scientists, which allows us to take a full picture approach to your product testing, registration, and marketing. We have the knowledge needed to assist with product testing, reviewing your product formula and label, completing your product listing and facility registrations, and helping you ensure your manufacturing facility is GMP compliant.
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Capacity
Do you have hundreds of cosmetics that now require annual product listings? SRC is here to help! We have over 20 full time consultants with the expertise and experience with CDER Direct and Cosmetics Direct to manage your product listings and label updates for both cosmetics and over-the-counter drugs.
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Experience
We have ample experience in CDER Direct (the drug product and facility listing platform) and have found the new Cosmetics Direct Portal to be substantially similar. Our team has a wide range of experience with all product types and regulating agencies, which allows us a unique perspective in interpreting and actioning on new and existing regulations.
FDA Registration Services
We provide expert guidance and hands-on support to help you navigate complex regulatory requirements with confidence. Our services are designed to reduce risk, improve accuracy, and keep your product on track for approval and market success.
FDA Registration Services
Get in touch with our team to learn how we support your regulatory goals and drive your success.
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