Welcome
PharmAdept PV Services Ltd is an independent Pharmacovigilance Consultancy providing services to the global Pharmaceutical industry.
PharmAdept has over 30 years of PV experience with diverse pharmaceutical companies, encompassing a wide range of global territories and business models, including complex matrix environments.
In today’s global pharma environment, coupled with the remote working aspects of the COVID19 challenge, we have a robust ability to operate effectively across time zones and establish strong alliances.
A Pragmatic Approach
PharmAdept takes a hands-on pragmatic, informed approach. Patient safety and compliance are at the heart of our services.
We believe that a successful pharmacovigilance function operates transparently and collaboratively, by establishing and cultivating trust-based partnerships, both cross functionally within the company and externally with business partners and external PV interfaces with HCPs and patients.
Our passion lies in the pragmatic establishment and maintenance of pharmacovigilance teams and systems, which underpin patient safety and uphold quality and compliance standards.
Pharmacovigilance Services
PharmAdept provide a comprehensive range of PV services to produce and maintain robust compliant PV systems in evolving and mature pharmaceutical and biotech organisations.
PV Compliance & Regulatory
- PV Road Map development & implementation
- Marketing Authorisation application & transfer
- EU & Local PSMF, EU QPPV Office, Local QPPV
- UK QPPV and UK National Contact for PV
- Health Authority PV RFIs
- NCA UK & EU Questionnaire Management
- Safety Evaluation & Risk Management
- Safety Communications, PBRER, RMP
- Data Compliance - xEVMPD, Article 57, EVDAS
PV Quality Management
- Procedural document production
- Procedural document management
- PV Inspection Readiness
- Regulatory PV Inspections
- PV audit preparation & management
- PV audit responses & CAPA
- PV CAPA QE deviation management
- KPIs & Compliance metrics
- PV system gap assessment & remediation
PV Governance
- Global Safety Committee
- PV Safety Data Evaluation
- PV Risk Management
- Product Recall Committee
- Global Safety Database Oversight Committee
- Labelling Committee
PV Operations
- DSUR & PBRER production management
- Literature review
- Regulatory Intelligence
- Case processing
- Safety data management
- Database governance
PV Partnerships
- Vendor management
- Business alliance partnering
Contact PharmAdept PV Services Ltd
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For all enquiries about any of our pharmacovigilance services, please fill out our quick form below.
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