CarlsbadTech’s Over-the-Counter Drug Approval (OTC) Regulatory Advisers

OTC drugs are found to be safe for use without the supervision of a health care professional, and they can be sold to consumers without a prescription. OTC drugs can be legally marketed without an application by following a regulation called an OTC drug monograph. OTC products that meet a monograph’s requirements may be marketed without FDA review.  Our Over-the-Counter Drug Approval (OTC) Regulatory Advisers have extensive knowledge in regulatory issues that are subject to the jurisdiction of the FDA. We offer consulting and regulatory services for all types of companies. Our regulatory strategy minimizes regulatory risk and ensures a speedy pathway for the launch of your OTC drug.  We can offer assistance in all phases of the product development cycle, including business planning, product development and testing.

Our range of services includes:

• Drug classification
• Generally Recognized As Safe and Effective (GRASE) conditions
• Labeling studies
• 505(b)(1), 505(b)(2), ANDA or OTC drug monograph applications
• NDA applications and Abbreviated New Drug Applications (ANDA) for generic OTCs
• Preparation and amendment of OTC Drug Monographs
• Adverse Event Reporting
• Documentation

An OTC Drug Approval Regulatory Adviser will help you with comprehensive regulatory services to significantly reduce the development time of your product. OTC Drug Approval Regulatory Advisers at our firm provide a range of regulatory and quality system consulting services. With unrivaled strategic expertise, we provide optimum solutions for both established and new companies globally. Our advisers and consultants have an outstanding track record of success with regulatory approvals at FDA.

With almost thirty years of experience in this field, our team of professionals can help you with all aspects of OTC drug compliance. We have several FDA compliance and inspection officials on board and a huge network of consultants with remarkable industry experience. Our firm is a leading provider of technical, compliance and regulatory services with multi-disciplinary expertise. We as OTC Drug Approval Regulatory Advisers ensure that your OTC product meets the standards for safety, efficacy and labeling. Contact us today for your regulatory requirements.