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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

Our Regulatory Affairs Consulting Services in Philippines portfolio covers:

Strategies

Regulatory Strategies / Expert Views

Regulations pertaining to pharmaceutical products are continuously changing...

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Authorizations

New Product Authorizations

Pharmaceuticals and other medicinal products need to be prior authorized by...

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Analysis

Gap Analysis and Remediation

A gap analysis is a regulatory review process that identifies data gaps in the technical...

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delig

Regulatory Due Diligence

Regulatory issues arise unexpectedly and can create significant strain on a company’s...

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Authorizations

API/DMF

DDReg provides expert consulting and efficient services for quality Drug Substance...

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CMC

CMC Advisory

When it comes to regulatory strategies, CMC documentation play a crucial role in developing...

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Approval

Post Approval Life Cycle Management

Managing the post-approval life cycle of a product is an essential component to sustaining...

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Regulatory Certification

Regulatory Certification

Administrative documents are an integral component of regulatory submissions and constitute key certifications...

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Regulatory Certification

ANDA and MA Holder Services

The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex....

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