Regulatory Services in USA
Regulatory Compliance Experts in USA
A robust regulatory system is important to ensure the safety, efficacy, and quality from pre-marketing to post-marketing phases of a medicinal product. The U.S. FDA is the governing regulatory authority in the USA for medicines, medical devices, biosimilars, vaccines, food supplements, pharmaceuticals, cosmetics, and more. The Center for Drug Evaluation and Research (CDER) issues different requirements for new drugs, generic drugs, and OTC drugs including New Drug applications (NDAs) and Abbreviated New Drug Applications (ANDAs). For new biologics a Biologics Licenses Application (BLA) is necessary for premarket approval. Thus, the U.S. FDA sets strict guidelines that manufacturers must follow to obtain compliant market authorization for their products depending on their category, which are also adopted by many other countries worldwide. However, due to the stringency of the guidelines and the ever-changing regulations many foreign manufacturers are unable to obtain compliant market authorization for their products.
As a leading global contender, DDReg’s Regulatory Services in USA 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. For the U.S. market, we provide comprehensive services for NDA and ANDA applications as per sections 505 (b)(2) and 505(j) respectively. In-house or monograph specifications, protocols, reports, and completed ANDA or NDA dossiers (modules 1, 2, 3, and 5) are thoroughly reviewed as per the U.S. FDA requirements. All queries are responded to and include adequacy review for submission. All post-approval or minor changes are conducted including annual reports filing and prior approval supplement. We provide assistance for all ANDA requests made by the U.S. FDA.
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