OTC Drugs

End-to-End Compliance Solutions for Over-the-Counter Drug Products

The SRC Team can support all of your over-the-counter drug compliance needs. We have strong expertise in applicable regulations and have collaborated with our clients through product development, adverse event issues, FDA inspections, and facility changes. Through this experience we have learned how to successfully manage a variety of complexities that may arise throughout the product life cycle. Our team can assist you with GMP books and records audits, registering facilities and listing products, data generation and review, adverse events reporting, and troubleshooting the testing and manufacturing processes. Partner with SRC and be confident you are achieving and maintaining proper compliance with your product.

Schedule a consultation

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.

Schedule Consultation

Knowledge

Our team has substantial knowledge of FDA regulations to collaborate with you on testing, marketing material reviews, compliance, and proper listing of over-the-counter drugs. Many of SRC’s team members have over 30 years of experience working with over-the-counter drug manufacturing and testing facilities.
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 help our clients stay on the forefront of industry and agency changes by providing updates on enforcement trends and upcoming regulatory shifts that may affect their product.
Deadline Management

The SRC Team has the capacity to process all of your product listings, facility registrations, OMUFA fee filings, and adverse event reporting for drug products, whether you have a single product or hundreds to manage. We have significant experience in CDER Direct and are prepared to act as an extension of your regulatory team.

Regulatory Solutions

OTC Drugs 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 Canadian Registration Other Services

View all services