Regulatory Affairs Service Provider in China
The pharmaceutical market in China is the second largest globally, driven by broader access to new drugs, evolving regulations, and a growing societal demand for medicinal products. Key regulatory bodies including the National Medical Products Administration (NMPA), the National Health Commission (NHC), and the Ministry of Human Resources and Social Security (MOHRSS) oversee drugs, medical devices, and traditional medicines.
The NMPA is structured into departments with distinct roles in pharmaceutical regulatory services in China. Its Department of Drug Regulation enforces Good Manufacturing Practice (GMP) in pharmaceutical manufacturing, conducts site inspections, manages pharmacovigilance activities like adverse reaction monitoring, and ensures compliance with regulations and laws. Similarly, the Department of Medical Device Regulation enforces GMP for medical devices , but medical regulatory services in China face increasing registration challenges, including stringent requirements and language barriers that complicate market entry for international manufacturers.
Why choose DDReg for Regulatory Services in China?
As a top-tier provider among regulatory affairs consulting firms in China, DDReg offers comprehensive support and tailored strategies throughout all regulatory phases. We continuously monitor the latest NMPA regulatory services in China requirements to ensure high-quality, timely submissions. Our services include robust safety measures, proactive risk management , and collaboration with specialists to streamline product launches, regulatory filings, and market authorizations.
Our Regulatory Consulting Services In China Portfolio Covers
- NMPA Regulatory Affairs Consulting
- Regulatory Strategies and Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- API/DMF
- eCTD Publishing and Submission Services
- ANDA and MA Holding
Our Regulatory Affairs Consulting Services in China portfolio covers:
Regulatory Strategies
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality...
New Product Marketing Authorizations
Navigating marketing authorization is a complex and time-sensitive process. Every country has its own regulatory framework...
Gap Analysis and Remediation
In the highly regulated pharmaceutical industry, maintaining compliance is critical. Regulatory gap analysis helps identify deficiencies in technical documentation...
Regulatory Due Diligence
Regulatory issues arise unexpectedly and can create significant strain on a company’s resources. As such, it is advisable for all companies to carry out regular and frequent regulatory due diligence and audits...
API & DMF services
Drug Master Files (DMFs) contain confidential and detailed information regarding API processes—from manufacturing to storage. DDReg’s DMF Services deliver precise...
CMC Advisory
DDReg’s CMC services are dedicated to assisting customers in developing robust and an efficient regulatory strategy through all development phases - authoring...
Post Approval Life Cycle Management
Maximize product value with expert pharma lifecycle management. Our dedicated team ensures that your product remains on shelves and compliant with ever-evolving regulations through strategic post-approval management...
Certification Services
Partner with DDReg to navigate the complex process of regulatory certification of pharmaceutical...
ANDA and MA Holder Services
Our comprehensive services support both Abbreviated New Drug Applications (ANDA) and Marketing Authorization processes.
Publishing & Submission
Our comprehensive digital solution transforms traditional paper dossier submissions into a streamlined electronic format. With robust infrastructure and cutting‐edge management processes...
