Regulatory Services in Colombia

Regulatory Compliance Experts in Colombia

The Colombia National Food and Drug Surveillance Institute, or Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA), was established in 1992 under the Ministry of Health to regulate drugs, medical devices , and biologics in the country. Local authorities periodically conduct inspections as a result of anonymous complaints or authoritative instructions to ensure compliance with regulation is met. Due to the comprehensive analysis regime, the INVIMA can take comparatively longer in granting a marketing authorization. For an innovator product, the authorization process is longer compared to a generic or drug that is listed on the Official Pharmacopeia. Similarly, the authorization time may be longer for biologics and biosimilars unless abbreviated routes are allowed, depending on the molecule, that could accelerate the process of obtaining marketing authorization.

As a leading global contender, DDReg’s regulatory services in Colombia provide ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.

Our Regulatory Consulting Services In Colombia Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regulatory Due Diligence
  • Gap Analysis and Remediation
  • New Product Authorizations
  • Post Approval Life Cycle Management
  • CMC Advisory
  • API -DMF
  • ICSR Processing and Submission
  • Risk Management
  • Aggregate Reports
  • Signal Management
  • QPPV Services
  • Bio Waiver Justifications
  • Clinical & Non-Clinical Experts Reports
  • IPR Support, including Worldwide Patent Status and Patent Reviews
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Country Specific Services

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Call us on:+1 (302) 601-2755