Skillpharma
Skillpharma is a company with over ten years of experience, highly specialized and always updated team, providing excellent services in Regulatory Affairs, Post Marketing Vigilance, Institutional Affairs, Scientific Service, and Market Access. It aims for technical and managerial excellence to create value and competitive advantage over time, bringing together skills from the pharmaceutical industry and public administration to support clients' core business development.
Industries
Nr. of Employees
small (1-50)
Products
preparation submission
Service for preparation and submission of Marketing Authorization (MA) variation applications including type IA/IB, type II, Line extension, MAH ownership transfers and MA renewals.
preparation and submission of Pediatric Investigation Plan
Service for preparation and submission of Pediatric Investigation Plans.
classificazione e
Classificazione e valutazione regolatoria claim nutrizionali per prodotti alimentari e integratori.
classificazione e predisposizione e/o revisione Technical File per dispositivi medici
Classificazione e predisposizione e/o revisione Technical File per dispositivi medici.
preparation or
Service for preparation, review, first submission, and subsequent revision submission of Active Substance Master File (ASMF).
preparation and/or revision of cosmetics dossier (Product Information File)
Service for preparation and/or revision of cosmetics dossier (Product Information File).
preparation submission
Service for preparation and submission of Marketing Authorization (MA) variation applications including type IA/IB, type II, Line extension, MAH ownership transfers and MA renewals.
preparation and submission of Pediatric Investigation Plan
Service for preparation and submission of Pediatric Investigation Plans.
classificazione e
Classificazione e valutazione regolatoria claim nutrizionali per prodotti alimentari e integratori.
classificazione e predisposizione e/o revisione Technical File per dispositivi medici
Classificazione e predisposizione e/o revisione Technical File per dispositivi medici.
preparation or
Service for preparation, review, first submission, and subsequent revision submission of Active Substance Master File (ASMF).
preparation and/or revision of cosmetics dossier (Product Information File)
Service for preparation and/or revision of cosmetics dossier (Product Information File).
Services
End-to-end regulatory support including marketing authorizations, dossier development (CTD/eCTD), variations, renewals, CMC review, labeling and interactions with national and European authorities for human and veterinary products, medical devices, cosmetics and borderline products.
Comprehensive PV services including provision of QPPV, ICSR processing, safety database management (E2B/21 CFR Part 11 compliant), PSMF management, PSUR/RMP preparation, literature monitoring, audits and inspection support.
Medical-scientific support including medical inquiries handling, preparation of medical information and advertising materials, Dear Doctor Letters, congress and investigator meeting organization, and cooperation with pharmacovigilance for medical review activities.
Assessment of product value, evidence gap analysis, preparation of HTA dossiers and reimbursement documents, generation of health-economic evidence and design of patient engagement and public-private initiatives.
Monitoring and analysis of political and institutional decision-making, stakeholder mapping, organisation of strategic meetings with decision-makers, and support in submission/pickup of documentation with public institutions.
End-to-end regulatory support including marketing authorizations, dossier development (CTD/eCTD), variations, renewals, CMC review, labeling and interactions with national and European authorities for human and veterinary products, medical devices, cosmetics and borderline products.
Comprehensive PV services including provision of QPPV, ICSR processing, safety database management (E2B/21 CFR Part 11 compliant), PSMF management, PSUR/RMP preparation, literature monitoring, audits and inspection support.
Medical-scientific support including medical inquiries handling, preparation of medical information and advertising materials, Dear Doctor Letters, congress and investigator meeting organization, and cooperation with pharmacovigilance for medical review activities.
Assessment of product value, evidence gap analysis, preparation of HTA dossiers and reimbursement documents, generation of health-economic evidence and design of patient engagement and public-private initiatives.
Monitoring and analysis of political and institutional decision-making, stakeholder mapping, organisation of strategic meetings with decision-makers, and support in submission/pickup of documentation with public institutions.
Expertise Areas
- Regulatory compliance and submissions (human and veterinary)
- Pharmacovigilance and post-market safety surveillance
- Medical and scientific affairs
- Clinical trial design and compliance support
Key Technologies
- eCTD electronic dossier compilation
- E2B safety reporting standard
- 21 CFR Part 11 compliant safety databases
- Pharmacovigilance safety database and PSMF management software
News & Updates
Vigilanza Post Marketing
Monitoring the safety of medicinal products on the market and detecting changes in their risk-benefit ratio, with tailored solutions and a specialized team.
Affari Istituzionali
Managing dialogue with public decision makers and developing relationships with stakeholders in the health sector.
Scientific Service
Providing medical-scientific advice and data management throughout the product lifecycle.
Whistleblowing
Implementing a process for reporting compliance violations with confidentiality and protection for whistleblowers.
Vigilanza Post Marketing
Monitoring the safety of medicinal products on the market and detecting changes in their risk-benefit ratio, with tailored solutions and a specialized team.
Affari Istituzionali
Managing dialogue with public decision makers and developing relationships with stakeholders in the health sector.
Scientific Service
Providing medical-scientific advice and data management throughout the product lifecycle.
Whistleblowing
Implementing a process for reporting compliance violations with confidentiality and protection for whistleblowers.