Pharmacovigilance | Pharma laws | Compliance
BoosConsulting offers independent, tailored and flexible consulting, hand-on support and interim management for pharma, biotech and healthcare - from short-term bridging in the event of resource bottlenecks to long-term support of products, projects and clients.
So that compliance with regulatory requirements is ensured, authority deadlines are met and the workload of you and your team gets noticeably reduced.
Based on twenty years of profound experience, I have a particular focus on pharmacovigilance (drug safety, patient safety); other core areas include specific services relating to medical devices and the field of pharmaceutical law.
Services (non-exhaustive):
Pharmacovigilance:
• Setting up / maintaining a pharmacovigilance system (incl. PSMF)
• Implementing regulatory requirements in pharmacovigilance (GVP, ICH, CIOMS, German Drug Act)
• EU QPPV, German Graduated Plan Officer (or deputy) ad interim
• Signal detection and management
• Risk Management Plans (RMPs)
• Periodic Safety Update Reports (PSURs)
• Trainings / seminars
• PV Agreements (PVAs) / Safety Data Exchange Agreements (SDEAs)
• SOPs for Headquarters or Affiliates
• Preparation and follow-up of Inspections / Audits, CAPAs
• Clinical trials: SAEs / SUSARs, DSUR, study protocol, study report
Medical devices:
• Classification, distinction issues
• Conformity assessment procedures / clinical assessment
• Vigilance / post-market surveillance
Pharmaceutical laws:
• Contract design
• Drug advertising law / Information Officer
• Data privacy (GDPR) / German Federal Data Protection Act (BDSG)
• Artificial Intelligence / AI Compliance Representative
For more information kindly visit www.BoosConsulting.de
Company Details
- Employees
- 1
- Address
- Darmstädter Str. 63, Weiterstadt (Bei Darmstadt),hessen 64331,germany
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://www.boosconsulting.de
- Keywords
- Pharmakovigilanz, Pharmacovigilance, Arzneimittelsicherheit, Pharmarecht, Pharma law, Medical Devices, Medizinprodukte, KI Compliance, AI Compliance.
- HQ
- Weiterstadt (bei Darmstadt), Hessen
- Competitors
- RMC - Dr. Renate Materna Consult, Lahn Pharma Services GmbH, Pharma-Support-Consulting GbR, Sanapharm Coaching und Consulting, Globi-Corp, SCRATCH Pharmacovigilance GmbH, SWB advice - Stefan W. Brinkmann - Unternehmensberatung, Lenolution, Emerson Consulting & Clinical Research Services, Reporting Solution.
Boosconsulting »pharmacovigilance By Passion!« Questions
Boosconsulting »Pharmacovigilance By Passion!«'s website is https://www.boosconsulting.de
Boosconsulting »Pharmacovigilance By Passion!«'s LinkedIn profile is https://de.linkedin.com/company/boosconsulting
Boosconsulting »Pharmacovigilance By Passion!« has
1 employees.
View email and phone details for 1
employees at Boosconsulting »Pharmacovigilance By Passion!«.
Boosconsulting »Pharmacovigilance By Passion!«'s industry is
Business Consulting and Services
Boosconsulting »Pharmacovigilance By Passion!«'s top competitors are
Rmc - Dr. Renate Materna Consult,
Lahn Pharma Services Gmbh,
Pharma-Support-Consulting Gbr,
Sanapharm Coaching Und Consulting,
Globi-Corp,
Scratch Pharmacovigilance Gmbh,
Swb Advice - Stefan W. Brinkmann - Unternehmensberatung,
Lenolution,
Emerson Consulting & Clinical Research Services,
Reporting Solution.
Boosconsulting »Pharmacovigilance By Passion!«'s categories are Business Consulting and Services
