OTC Services

Regulatory Services for OTC Products

Regulatory Expertise in OTC Drug Products and Drug Production

At REJIMUS, we provide extensive regulatory expertise to ensure your over-the-counter (OTC) products meet all FDA compliance requirements for all things 21 CFR Part 211 related, from traditional OTC to Cosmetic Drugs. Our services include managing FDA compliance, addressing warning letters, and overseeing import processes to ensure your products adhere to federal regulations. We assist with regulatory submissions for NDC’s and registrations, along with all the operational controlled documentation, record keeping, facility auditing and training required.

Quality Assurance & Quality Control Oversight

In terms of quality assurance, REJIMUS is dedicated to establishing and maintaining cGMP-compliant facilities for your OTC products – from ingredient qualifications to labeling. In the event of needing to recall a product or ingredient, our Recall Management Services are comprehensive, ensuring swift and effective action if necessary, and accurate reporting to the FDA. We optimize quality systems for efficiency and compliance, ensuring your operations meet FDA requirements, including that of any supply chain partners as required by law.

Product & Operational Compliance

REJIMUS ensures that your OTC products comply with all regulatory requirements related to labeling, packaging, manufacturing and testing. Whether a drug testing lab, or drug manufacturing facility, distribution partner or retailer, we ensure compliance with all applicable regulations.

Should there be a need for critical investigations or troubleshooting, we’re the team that gets it done! Our Expert Witness services provide your company with expert testimony and support in legal matters, ensuring you have the necessary expertise in legal and/or quality disputes.


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