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Regulatory Services in Latvia

Regulatory Compliance Experts in Latvia

The State Agency of Medicines of Latvia (SAMLV) is the regulatory agency that oversees all functions involved in the regulation of medicinal product. The SAMLV is part of the Ministry of Health and works alongside institutions such as the National Health Service and the Health Inspectorate of the Republic of Latvia to implement regulations and legislations that have been established by the pharmacovigilance and Medical Treatment laws. Medicinal products are only allowed to be distributed in Latvia if they are registered and licensed in Latvia, any EU Member State, or a European Economic Area (EEA) state. The SAM encourages applicants to use decentralized, mutual recognition or national procedures. Market authorization applications through centralized procedures must be submitted to the European Medicines Agency (EMA). Marketing authorization renewals are conducted in line with the EU guidelines and requirements, as Latvia is a Member State of the EU. The SAM has also implemented stringent guidelines for the transfer of Marketing Authorization Holders (MAHs). Hence, navigating through relevant legislations, requirements, and guidelines can be challenging for MAHs.

As a leading global contender, DDReg’s Regulatory Services in Latvia 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 Latvia Portfolio Covers

  • Regulatory Strategies and Expert Views
  • Regultory 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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