Regulatory Services for Consumer Healthcare Products

Consumer health care products, including over-the-counter (OTC) drugs, medical devices, and supplements, are vital for public health. They require strict adherence to safety, efficacy, and quality standards to ensure consumer trust and regulatory compliance.

Regulatory Landscape Overview

Below is an overview of the regulatory landscape for key markets:

RegionRegulatory BodyPrimary RequirementsUnique ChallengesTimeline for Approval*Recent Update
United StatesFood and Drug Administration (FDA)Compliance with OTC Mono-graph and NDA requirementsComplex labeling and formulation approvals12-18 monthsUpdates to OTC sunscreen and monograph reform, see FDA Updates.
European UnionEuropean Medicines Agency (EMA), Medical Device Regulation (MDR)Compliance with MDR and pharmacovigilance guidelinesTransitioning from MDD to MDR compliance12-24 monthsNew MDR updates for Class II and III devices, see EMA Notices.
JapanPharmaceuticals and Medical Devices Agency (PMDA)Approval under PMDA standards, post-market surveillanceComplex pre-market clinical data requirements12-24 monthsRevisions to PMDA submission guidelines, see PMDA Updates.
ChinaNational Medical Products Ad-ministration (NMPA)Pre-market approvals, clinical data submissionsComplex testing requirements18-36 monthsUpdates to NMPA guidelines for imported devices, see NMPA News. NMPA News.
CanadaHealth CanadaLicensing under Health Cana-da’s Drug and Device ProgramsAligning bilingual labeling12-18 monthsRevised labeling and clinical trial requirements, see Health Canada Updates.
AustraliaTherapeutic Goods Administra-tion (TGA)Compliance with TGA regula-tions for OTC and medical de-vicesNavigating dual regulations for combo products12-18 monthsNew guidelines for OTC product submissions, see TGA News.

* Timelines are approximate and can vary based on the complexity of the product, completeness of submissions, and regulatory authority review processes.

Our Regulatory Services

We offer comprehensive support to ensure compliance for cleaning and hygiene products:

Regulatory Strategy

Regulatory Strategy and Submissions

  • Preparing regulatory submissions for OTC drugs, medical devices, and supplements.
  • Assisting with clinical trial protocols and study data submissions.
Labeling and Advertising Compliance

Labeling and Advertising Compliance

  • Developing compliant product labels for global markets.
  • Ensuring advertising and promotional materials meet regulatory standards.
Safety and Quality Assurance

Safety and Quality Assurance

  • Conducting product safety assessments and risk analyses.
  • Assisting with Good Manufacturing Practice (GMP) compliance.
Post-Market Support

Post-Market Support

  • Monitoring product performance and safety post-launch.
  • Supporting adverse event reporting and recalls if necessary.

Market Supported

Market Supported Map

Case Study/Blogs/Insights

Rely on our expertise to navigate the regulatory complexities of personal accessories and articles. We help you ensure safety, compliance, and consumer satisfaction in global markets.

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