Antiseptics

Regulatory Expertise Rooted in the History and Future of Antiseptic Products

Many of SRC’s team members began their careers with hand sanitizer and antiseptic product testing, manufacturing, and registration and have been working with FDA registered products since the development of the 1994 Tentative Final Monograph for Healthcare Antiseptic Drug Products and the 1991 Tentative Final Monograph for First Aid Antiseptic Drug Products. Our team combines 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.

We can support your team with testing, monograph questions, reformulation and ingredient sourcing, as well as product and facility registrations for your antiseptic hand washes and rubs. We also have consultants specializing in Good Manufacturing Practices who can train your team or conduct audits to ensure you are following proper books and records procedures throughout the manufacturing practices.

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Your Regulatory Partner

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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Knowledge

We have a lengthy history with antiseptic registration and have stayed up to date on the regulatory changes and trends in antiseptic registration over the years. We use this in-depth knowledge to guide our clients to develop the best data and labels possible to give your product the ideal prospect for long-term success. We actively monitor the changing landscape in this space and provide our clients with key updates that may affect their products.
Deadline Management

The SRC Team is available to process your product listings, facility registrations, and adverse event reporting on your behalf to take the stress of managing numerous deadlines off of your team. We have significant experience in CDER Direct and are prepared to act as an extension of your regulatory team.

Experience

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.
Trends Analysis

In addition to our registration and testing support, our team participates in trade groups and consistently monitors warning letters. We use this information to assist our clients in staying at the forefront of industry and agency changes by providing updates on enforcement trends and upcoming regulatory shifts that may impact their product.

Regulatory Solutions

Antiseptics 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.

Study Management FDA Registration Canadian Registration Other Services

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