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Regulatory Services in Philippines

Regulatory Compliance Experts in Philippines

The Food and Drug Administration (FDA) of Philippines regulates and oversees the safety, efficacy, and quality of pharmaceutical products that include medical devices, cosmetics, and food in addition to medicines. The medical device and pharmaceutical markets in the Philippines rely on foreign manufacturers which creates ample opportunities for foreign organizations that wish to enter the market. To distribute medicinal products in Philippines, pharmacovigilance consulting firm must obtain a product registration certificate and a License to Operate from the FDA. However, the requirements for the certificate application are different depending on whether the product is a new drug or a generic. Navigating through these requirements can be challenging for foreign manufacturers that are unfamiliar with the market. Therefore, for successful product registration and market authorization, manufacturers are encouraged to partner with those that have successful experience in the market.

As a leading global contender, DDReg’s regulatory services in Philippines provides 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 Philippines 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
Contact our experts today !
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Call us on:+1 (302) 601-2755
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