Regulatory Services in Mexico
Regulatory Services in USA
Regulatory Services in Canada
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 Spain
Regulatory Compliance Experts in Spain
The Spanish Agency for Medicines and Medical Devices, or Agencia Española de Medicamentos y Productors Sanitarios (AEMPS), of the Ministry of Health has exclusive authority to approve, license, and monitor safety, efficacy, quality, and compliance of pharmaceutical and medicinal products across Spain. Additionally, it regulates and authorizes clinical trials in accordance with the European Medicines Agency (EMA). The AEMPS provides guidelines on registration, pharmacovigilance, clinical trials, availability, formulations, packaging and labelling for medicinal products intended for human use. These are consistently reviewed and updated. Additionally, the AEMPS is also authorized to disclose non-public information to the U.S. FDA for pre-marketing and post-marketing activities of AEMPS-regulated drugs. Hence, all products for human and/or veterinary use are evaluated, authorized, monitored, and supervised while maintaining compliance with regional guidelines. Manufacturers seeking successful market authorizations for their products in Spain are advised to ensure they are informed on all the guidelines and requirements set by the AEMPS.
As a leading global contender, DDReg’s regulatory services in Spain 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
