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Regulatory Services in Singapore

Regulatory Compliance Experts in Singapore

The Health Sciences Authority (HSA) of the Ministry of Health (MoH) is the agency that is responsible for the regulation of therapeutic products in Singapore. It is important to note that medical devices, health supplements, traditional medicines, Chinese proprietary medicines, and cosmetic products do not fall under the ‘therapeutic products’ category and have separate regulations of their own. Depending on the nature of the product, a Clinical Trial Authorization (CTA) may be required before clinical tests can be conducted. Therapeutic products must be registered with the HSA where different application forms exist for new drug application, generic drug application, biosimilar product application and submissions of drug master file and plasma master file. The product is assessed on its Good Distribution Practice and Good Manufacturing Practice requirements before a dealer’s license and certification can be issued. If this is not achieved, then the product will not be approved for distribution within the country. Similarly, a license and certification are also required for medical devices. Pharmacovigilance consulting firm may face challenges in navigating through the various requirements set by the HSA for obtaining marketing authorization for their products.

As a leading global contender, DDReg’s regulatory services in Singapore provides on-going support and development of the 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 Singapore 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 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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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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