services

Here we present our consulting and services. These pages are always kept up to date. If you still do not find what you are looking for, just contact us - we are happy to help.

Our consulting and services

BoosConsulting supports you in the areas
• pharmacovigilance
• pharmaceutical law
• Medical Devices

pharmacovigilance - Consulting and services for developing substances and established preparations

Description of the Pharmacovigilance System in the Pharmacovigilance System Master File (PSMF)
Implementation of national / international legal pharmacovigilance requirements (eg ICH, Good Pharmacovigilance Practice / GVP)
Development / implementation of in-house global pharmacovigilance standards, Brexit support
Implementation / Evaluation / Optimization of the Pharmacovigilance System in Local Offices
Process descriptions (SOPs, WIs) and templates

Takeover of interim positions
Strategic PV planning
Support in resource management and recruitment
Support for budget planning

European Qualified Person for Pharmacovigilance, EU QPPV (or substitutes)
Step-by-step representative according to §63a AMG (or deputies)

Cumulative signal detection and evaluation
Benefit-risk assessments of medicines
Creation of risk management plans (RMPs) including risk minimization measures
Support / Management of Medical Alerts

Preparation and follow-up of government inspections and internal PV audits, including CAPA development / management
Assistance with shortcomings, European risk procedures (referrals)

Preparation of Periodic Safety Reports - Periodic Safety Update Reports (PSURs)
Generating annual safety reports as part of clinical trials - Development Safety Update Reports (DSURs)

pharmaceutical law - Advisory services and 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
Mergers & Acquisitions support
Demarcation issues (drugs, medical devices)
General Data Protection Regulation (DSGVO), in particular in pharmacovigilance

Medical Devices - market access and security monitoring services

Support in the vigilance of medical devices and cosmetics
Conformity assessment procedures
Clinical Evaluation Reports, PSURs, Post-market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF)
Demarcation issues (pharmaceuticals, medical devices, cosmetics

consultation

As a customer, you are the center of attention. We want you to find exactly the right product and service. That is why extensive consulting is our top priority: so that you can make informed decisions.

sale

We want you to be satisfied with our products and services. That is why we not only advise you before you buy, but also assist you afterwards with advice and assistance and remain your reliable contact.

training

We regularly offer training and workshops on industry-related topics. Our certified trainers are seasoned experts in their field and always look forward to working with our customers.

quality

We place the highest value on first-class quality. Only products that meet our high quality standards will find their way into the sale. We ensure this quality through regular and extensive product testing.

efficiency

Time is money - also for our customers. That's why we work in optimized processes and with a well-rehearsed team. So we can guarantee that we can serve you promptly and that there are no waiting times.

Fair prices

Transparent prices are the basis for a trusting cooperation. That's why we make our prices understandable and fair. It is important to us that our suppliers are also paid appropriately for their work!