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Regulatory Services in Malaysia
Regulatory Services in Singapore
Regulatory Services in India
Regulatory Services in China
Regulatory Services in Indonesia
Regulatory Services in Philippines
Regulatory Services in Vietnam
Regulatory Services in Morocco
Regulatory Services in UAE
Regulatory Services in Kenya
Regulatory Services in Turkey
Regulatory Services in Saudi Arabia
Regulatory Services in Jordan
Regulatory Services in Egypt
Regulatory Services in Colombia
Regulatory Services in Japan
Regulatory Services in South Korea
Regulatory Services in Kazakhstan
Regulatory Services in Italy
Regulatory Services in Latvia
Regulatory Services in UK
Regulatory Services in Belgium
Regulatory Services in Spain
Regulatory Services in Australia
Regulatory Services in South AfricaRegulatory 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 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 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
Country Specific Services
- Regulatory Strategies / Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- Regulatory Services in India
- Regulatory Services in Mexico
- Regulatory Services in USA
- Regulatory Services in Canada
- Regulatory Services in Malaysia
- Regulatory Services in Singapore
- Regulatory Services in China
- Regulatory Services in Indonesia
- Regulatory Services in Philippines
- Regulatory Services in Vietnam
- Regulatory Services in Morocco
- Regulatory Services in UAE
- Regulatory Services in Kenya
- Regulatory Services in Turkey
- Regulatory Services in Saudi Arabia
- Regulatory Services in Jordan
- Regulatory Services in Egypt
- Regulatory Services in Colombia
- Regulatory Services in Japan
- Regulatory Services in South Korea
- Regulatory Services in South Africa
- Regulatory Services in Kazakhstan
- Regulatory Services in Italy
- Regulatory Services in Latvia
- Regulatory Services in UK
- Regulatory Services in Belgium
- Regulatory Services in Spain
- Regulatory Services in Australia
- Aggregate Reports
- Literature Monitoring
- Risk Management
- ICSR Processing & Submission
- Signal Management
- Audit and Compliance
- QPPV Services
- Pharmacovigilance Services in Mexico
- Pharmacovigilance Services in USA
- Pharmacovigilance Services in Canada
- Pharmacovigilance Services in Malaysia
- Pharmacovigilance services in Singapore
- Pharmacovigilance Services in India
- Pharmacovigilance Services in China
- Pharmacovigilance Services in Indonesia
- Pharmacovigilance Services in Philippines
- Pharmacovigilance Services in Vietnam
- Pharmacovigilance Services in Morocco
- Pharmacovigilance Services in Kenya
- Pharmacovigilance Services in Turkey
- Pharmacovigilance services in Saudi Arabia
- Pharmacovigilance Services in Jordan
- Pharmacovigilance Services in Egypt
- Pharmacovigilance Services in Japan
- Pharmacovigilance services in South Korea
- Pharmacovigilance Services in South Africa
- Pharmacovigilance Services in Kazakhstan
- Pharmacovigilance Services in Australia
- Pharmacovigilance services in UAE
- Pharmacovigilance Services in Colombia
- Pharmacovigilance services in Italy
- Pharmacovigilance services in Latvia
- Pharmacovigilance services in Belgium
- Pharmacovigilance services in Spain
- Pharmacovigilance services in UK
- DDReg's Publishing services
- DDReg's Medical Writing services
