OVER-THE-COUNTER DRUGS
OTC drugs are available in various dosage forms, including tablets, capsules, syrups, creams, ointments, lotions, gels, and shampoos. Each product must align its active ingredients, indications, dosage, warnings, labeling, manufacturing requirements, and registration details with the appropriate regulatory pathway. ProConXol helps companies evaluate these requirements, prepare for launch, and maintain ongoing regulatory compliance throughout the product lifecycle.
Discuss Your OTC Drug ProductA PRACTICAL STARTING POINT
We help determine whether the proposed product fits an applicable OTC monograph, requires a different formulation or claims strategy, or may need an approved application pathway. The work is tailored to the product, manufacturer, business role, and target market.
HOW WE CAN HELP
Review active ingredients, dosage form, route, indication, patient population, directions, warnings, and claims against the intended pathway. Identify gaps, options, and decisions before significant launch investment.
Develop, assess, and improve quality management systems for OTC drug manufacturers in compliance with FDA cGMP requirements (21 CFR Parts 210 and 211), including SOPs, validation, supplier controls, production and laboratory controls, deviations, CAPA, complaints, change control, and recordkeeping.
Develop or review Drug Facts labeling, principal display information, warnings, directions, inactive ingredients, packaging, websites, NDC number, and promotional materials for consistency with applicable requirements and the product’s lawful marketing basis.
Support OTC drug manufacturers with establishment registrations, state licensing, NDC number assignments, product listings, SPL submissions, and renewal management to maintain compliance with FDA’s 21 CFR Part 207 and applicable state requirements.
Help teams understand the documentation, coordination, and operational implications of the current OTC monograph framework and OMUFA when relevant.
Support adverse-event and complaint processes, investigations, trend review, safety escalation, recall handling with regulatory agencies, field actions, and responses to agency questions.
Prepare facilities and teams through gap assessments, mock inspections, document readiness, staff coaching, observation responses, remediation plans, and CAPA follow-through.
Prepare and manage global registration dossiers for OTC drugs, including submissions and compliance coordination with regulatory agencies in markets such as the U.S., EU, Canada, and other international jurisdictions.
Support compliant global trade in OTC drug products through import/export procedure guidance, international trade compliance, documentation review, detention resolution, and preparation of export certificates (FSC, CoE, CFG) and regulatory documentation.
Access experienced regulatory professionals through flexible remote staffing solutions tailored to your project needs and business requirements. We provide contract-based hourly, fixed-rate, part-time, and full-time regulatory personnel, significantly reducing the cost and commitment of traditional hiring.
WHY IT MATTERS
Drug establishment registration, product listing, and inclusion in the NDC Directory do not mean FDA has approved the product or verified the submitted information. Public-facing copy and internal teams should use precise language about product status.
COMMON QUESTIONS
No. The applicable requirements depend on the active ingredient, dosage form, route, indication, population, directions, warnings, and other product details.
Yes. We can support labeler-code, establishment-registration, drug-listing, NDC data, and SPL activities based on the company’s role and responsibility.
No. An NDC identifies a listed drug product. Registration and listing do not, by themselves, establish that FDA approved the product.
Yes. We can review labels and promotional content together to improve consistency with the product’s lawful marketing basis and reduce misleading or unsupported language.
LET’S MOVE FORWARD
Share your formulation, proposed claims, draft label, manufacturing arrangement, and target launch date. We will help you identify the right workstream and the records needed to support it.
