Services
BoosConsulting
supports you in the following areas:
The overview of the consultancy and services are continuously updated. If you do not find exactly what you are looking for, just contact me
- I'll be pleased to help.
Pharmacovigilance - advisory and supporting services for development compounds and established products
- Compilation and maintenance of the Pharmacovigilance System Master File (PSMF)
- Implementation of national / international legal pharmacovigilance requirements (e.g. ICH, Good Pharmacovigilance Practices / GVP)
- Developing and establishing company-internal global PV standards
- Setting-up / Optimizing PV systems in affiliates
- Development and revision of process descriptions (SOPs, WIs) and templates
- Taking over of interim positions
- Strategic PV planning
- Support in resource management and recruitment
- Support in budget and cost centre planning / maintenance
- European Qualified Person for Pharmacovigilance, EU QPPV (or Deputy)
- German Graduated Plan Officer acc. to §63a German Drug Law (or Deputy)
- Cumulative signal detection and evaluation
- Benefit-risk assessments of medicinal products
- Setting up Risk Management Plans (RMPs) and Risk Minimization Measures
- Support in / Management of medical alert situations
- Preparation and follow-up Health Authority Inspections / Audits incl. CAPA development
- Support in handling Health Authority deficiency letters, European risk procedures (referrals)
- Preparation of Periodic Benefit Risk Evaluation Reports (PBRERs) - Periodic Safety Update Reports (PSURs)
- Generating annual safety reports for clinical trials - Development Safety Update Reports (DSURs)
- Pharmacovigilance training for PV and non-PV staff (in-house, affiliates, CROs)
- Training in medical-scientific content
- Medical-scientific presentations
- Generating annual safety reports for clinical trials - Development Safety Update Reports (DSURs)
- Support for documents in the context of
- clinical trials (Clinical Trial Protocols, Safety Reporting Plans, Case Report Forms, Marketing Authorization Application Documents, Investigator's Brochures)
- non-interventional studies (NIS)
- PASS / PAES (post-authorization safety studies / post-authorization efficacy studies)
- Medical assessments of ICSRs from clinical trials and post-marketing experiences for development compounds & established products
- Response preparation to product-specific medical-scientific requests sent by patients, pharmacists, physicians
- Creation / maintenance of safety profile documents (e.g. CCDS, CCSI, SmPC)
- Expert statements on requests from Health Authorities
- Medical Writing (e.g. for Regulatory & Medical Affairs)
- Preparation of complex medical-scientific content (e.g. in the context of an Expert’s Report)
Pharmaceutical laws - advisory and supporting services for the implementation of legal requirements
- Creation / Maintenance of Pharmacovigilance Contracts (PV Agreements / SDEAs)
- Contract design (pharmacovigilance, clinical trials)
- Other interface issues between pharmacovigilance and pharmaceutical law
- Support of Mergers & Acquisitions
- Distinction issues (drugs, medical devices)
- General Data Protection Regulation (GDPR), in particular in pharmacovigilance
Medical Devices - advisory and supporting services for market access and safety surveillance
- Support in the Medical Devices Vigilance & Cosmetics Vigilance
- Conformity assessment procedures
- Clinical Evaluation Reports, PSURs, Post-market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
- Distinction issues (medicinal products, medical devices, cosmetics)
Since this overview can’t capture the entire consultancy and service package, don't hesitate to contact me for more detailed information and an individual offer tailored to your particular situation.