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Regulatory Services in China

Regulatory Compliance Experts in China

The pharmaceutical market in China is the second largest in the world due to the increase in access to new drugs, changes in regulations, and the society’s increased need for medicinal products. The regulatory bodies in China that are responsible for governing drugs, medical devices, and traditional medicines include the National Medical Product Administration (NMPA), the National Health Commission (NHC), and the Ministry of Human Resources and Social Security (MOHRSS). The NMPA is further divided into organizations that each have their own functions regarding medicinal product regulation. The Department of Drug Regulation organizes and supervises Good Medical Practice (GMP) implementation and inspects manufacturing sites as required. It also oversees pharmacovigilance Solutions activities such as monitoring adverse reactions and resolves issues regarding compliance with regulations and laws.Similarly, the Department of Medical Device Regulation drives the implementation of GMP for medical devices . However, the requirements for registration processes are increasingly becoming stringent, coupled with language barriers, that may be challenging for international manufacturers who wish to obtain market authorization in China.

As a leading global contender, DDReg’s regulatory services in China 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 China 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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