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Regulatory Services in India
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Regulatory Services in Latvia
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Regulatory Services in Australia
Regulatory Services in South AfricaRegulatory Services in India
Regulatory Compliance Experts in India
The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory authority (NRA) of India that is responsible for the safety, efficacy, quality, and control of conducting clinical trials, implementing drug standards, controlling the quality of imported drugs and for coordinating State Drugs Control Organizations activities. It falls under the Directorate General of Health Services under the Ministry of Health and Family Welfare as part of the Indian Government. CDSCO aims to provide transparency, accountability, and uniformity in its drug evaluation services to guarantee the safety, efficacy, and quality of medications that are manufactured, imported, and sold in the country. Drugs and cosmetics are regulated by central and regional authorities under the Drugs & Cosmetics Act of 1940 and the rules of 1945. The State Drug Regulatory Authorities (SDRAs) exist at state levels for regional drug regulation and are often conjoined with the FDA of the state which often leads to complications in differentiating regulatory responsibilities and can contribute to hinderance of the administration processes at early stages. Additionally, the stringency of the requirements set by the CDSCO can pose challenges for manufacturers that wish to obtain marketing authorizations for their medicinal product, for the Indian market.
As a leading global contender, DDReg’s regulatory services in India 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 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
