Regulatory Pharma Net
Regulatory Pharma Net is a comprehensive provider of regulatory, market access, and pharmacovigilance services for pharmaceutical and life science companies. With over 25 years of expertise, they offer end-to-end support across the entire product lifecycle, including regulatory affairs, clinical trial management, market access strategies, and quality compliance. Their mission is to maximize the potential of healthcare solutions through tailored, integrated solutions and a human touch, ensuring successful regulatory outcomes and market entry across international markets.
Industries
Nr. of Employees
small (1-50)
Regulatory Pharma Net
Services
Strategic regulatory planning, dossier development, lifecycle management and interaction with competent authorities for medicinal products and medical devices.
Document-level formatting, eCTD-ready templates, conversion of paper applications to eCTD, building and validations, and lifecycle submission management.
QPPV coverage, PSMF preparation, literature monitoring, ICSR handling and electronic submission support to regional and national safety databases.
Early access program design, pricing and reimbursement dossier development, health-economic models and negotiation support with health authorities.
Technical file and CE marking support, clinical investigation strategy, vigilance reporting, EUDAMED interaction and PRRC services for medtech products.
Implementation and maintenance of quality management systems, ISO certification support, gap analysis and preparation for regulatory inspections including remote audits.
Strategic regulatory planning, dossier development, lifecycle management and interaction with competent authorities for medicinal products and medical devices.
Document-level formatting, eCTD-ready templates, conversion of paper applications to eCTD, building and validations, and lifecycle submission management.
QPPV coverage, PSMF preparation, literature monitoring, ICSR handling and electronic submission support to regional and national safety databases.
Early access program design, pricing and reimbursement dossier development, health-economic models and negotiation support with health authorities.
Technical file and CE marking support, clinical investigation strategy, vigilance reporting, EUDAMED interaction and PRRC services for medtech products.
Implementation and maintenance of quality management systems, ISO certification support, gap analysis and preparation for regulatory inspections including remote audits.
Expertise Areas
- Regulatory affairs and submissions
- Market access and pricing & reimbursement
- Pharmacovigilance and safety surveillance
- Clinical trial authorisation and management
Key Technologies
- Electronic Common Technical Document (eCTD) authoring and validation
- Regulatory submission portals and eSubmission platforms (CESP / IRIS‑style)
- Pharmacovigilance databases and signal management systems (EudraVigilance‑style)
- Serialization and unique identifier 2D matrix code systems
News & Updates
An event in Basel, Switzerland, on 05/06-05/2025.
An event in Basel, Switzerland, on 18/20-03-2025.
An event in Milan, Italy, on 17/19-03-2025.
An event in Amsterdam, Netherlands, on 05/06-03-2025.
An event in Milan, Italy, on 26/27-02-2025.
FDA's new ESG NextGen for electronic submissions starting April 14, 2025.
An event in Basel, Switzerland, on 05/06-05/2025.
An event in Basel, Switzerland, on 18/20-03-2025.
An event in Milan, Italy, on 17/19-03-2025.
An event in Amsterdam, Netherlands, on 05/06-03-2025.
An event in Milan, Italy, on 26/27-02-2025.
FDA's new ESG NextGen for electronic submissions starting April 14, 2025.