Raphe Pharmaceutique FDA Over the Counter (OTC) Drug Approval Consultants

Over the counter (OTC) drug products are defined as drug that do not require a medical prescription. They are safe and effective for use without treatment from a healthcare provider. The FDA reviews the active ingredients and labeling of these OTC drug. There are over 300,000 OTC drug products marketed in the United States. The FDA conducts a regulatory review that is based on the active pharmaceutical ingredient and labeling by therapeutic class rather than by evaluating individual drug formulations.

Firms intending to market a new product or OTC drug must submit an NDA (505) (b)(1) or 505(b)(2) application. Meeting FDA requirements can be a long process in most cases. An experienced staffs can assist you with the complicated process of submission, compliance and filing.

The two regulatory pathways for OTC drug in the United States are firstly, development under the OTC monograph process: or secondly, through the New Drug Application (NDA) process. Products that do not meeting the conditions of the OTC drug monograph must seek approval through the NDA process.

Our services as an FDA Over the Counter Drug Approval Consultants include:

  • Drug classification
  • Labeling assistance
  • OTC drug monograph applications
  • Prescription to OTC switch applications
  • Preparation of Time and Extent Application (TEA) for OTC Drug Monograph amendment
  • Assistance to meet post-approval requirements
  • US Agent

Our in-house consultants work with you through all the phases of the process and ensure timely approval and marketing of your OTC product. Our compliant department is well experienced with regulatory strategies to ensure prompt and speedy FDA compliance in all phases of the approval process. We have over two decades of experience in assisting firms with the FDA approval pathway for OTC drug.

Our consultants have an in-depth understanding of FDA regulations and can determine the appropriate drug classification (monograph or ANDA) and also help prepare compliant labels according to the OTC drug monograph. What’s more, our consulting services are quicker and more cost-efficient than other firms in this domain.