Pharmacovigilance & Safety

Pharmacovigilance Audits and Inspections

Global Pharmacovigilance and Drug Safety Local Pharmacovigilance Pharmacovigilance & Safety

Local Pharmacovigilance

Local Pharmacovigilance (PV) in the Nordics
We can provide local affiliate PV set-up and Local PV contact person in the Nordic countries:
such as setting up the whole Quality Management System (QMS) from start or parts of it as applicable, perform case handling, local literature review, PV intelligence, management of additional Risk Minimisation Measures, reconciliation of potential AE sources, and more.

Our colleagues in Regulatory Affairs can provide you with all necessary local regulatory support to meet the different local regulatory requirements in the different Nordic countries.

Adverse Event/Reaction Management (Human and Veterinary)
We assist with collection, validation, triage, follow-up, data management including data entry into Eudravigilance (Human/VET), MedDRA/VeDDRA coding, quality management, evaluation, submission to partners/EV/MHRA portal, reconciliation and archiving.

Risk Management Plan and Risk Minimisation Measures
We provide strategic advice, creation, medical and regulatory review, update and submission of Risk Management Plan (RMP).

We support with creation, implementation and tracking of Risk Minimization Measures (RMM).

Safety Physician, Advice
We can provide assistance with all safety physician tasks and roles all the way from medical review of regulatory documentation to global strategic safety and pharmacovigilance advisory roles, during the entire life cycle of your product.

Veterinary Surgeon
We can provide you with a veterinarian to support your company with 24/7 coverage, offering medicinal assessments of adverse events and signals, as well as addressing medicinal inquiries related to veterinary medicines.

Pharmacovigilance (PV) QMS
We perform GAP-analyses of your PV QMS.
We set-up new PV QMS tailored to your needs, develop and maintain your existing PV QMS.
We create, update and maintain of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates.

Business Continuity Plans (BCP)
We can assist with creating and maintaining a Business Continuity Plan as well as creating and performing BCP tests and Set-up of BCP risk assessment scheme.

Agreements
We can create, support, maintain Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), etc.
We also help you with vendor assessment, negotiation, vendor selection, set-up and maintenance of contracts, vendor management.

Global Pharmacovigilance / Drug Safety

EU&UK QPPV/Deputy QPPV
The roles of the EU QPPV and UK QPPV are required in the respective regulations from EMA and MHRA. Our experienced personnel can perform these roles for both human and veterinary medicines, including medically qualified backup personnel (physician, veterinarian) available as legally required.

We also provide the role of a Deputy EU QPPV and Deputy UK QPPV for both human and veterinary medicines.

We also provide QPPV EudraVigilance registration support.

Safety Physician, Advice
We can provide assistance with all safety physician tasks and roles all the way from medical review of regulatory documentation to global strategic safety and pharmacovigilance advisory roles, during the entire life cycle of your product.

Veterinary Surgeon
We can provide you with a veterinarian to support your company with 24/7 coverage, offering medicinal assessments of adverse events and signals, as well as addressing medicinal inquiries related to veterinary medicines.

Pharmacovigilance (PV) QMS
We perform GAP-analyses of your PV QMS.
We set-up new PV QMS tailored to your needs, develop and maintain your existing PV QMS.
We create, update and maintain of Standard Operating Procedure (SOP), Working Instruction (WI) and Templates.

Pharmacovigilance System Master File (PSMF)
Creation, update and maintenance of the PSMF and Summary of Pharmacovigilance System (SPS).

Risk Management Plan and Risk Minimisation Measures
We provide strategic advice, creation, medical and regulatory review, update and submission of Risk Management Plan (RMP).

We support with creation, implementation and tracking of Risk Minimization Measures (RMM).

Safety Database
We can help you implement, validate and maintain your Safety Database including performing periodic reviews and assessments .

We support in creating User Requirement Specification (URS), Risk Impact Assessments, Validation Plans, Test Approach, Test Reports, Validation Reports, System List/Registers, necessary support and maintenance procedures and forms (governing user access, security, change control, validation, problems and incident, back-up and restore, business continuity, periodic reviews etc).

PV in geographical expansion /Market Acquisitions/DD (due diligence)
We support and lead PV teams in Due Diligence/Market Acquisitions/Geographical expansion projects going into new markets or regions globally.

Improvement projects
We have experience of driving different PV improvement and transformation projects both globally and locally, to increase efficiency and quality while still having a pragmatic and lean approach.

Business Continuity Plans (BCP)
We can assist with creating and maintaining a Business Continuity Plan as well as creating and performing BCP tests and Set-up of BCP risk assessment scheme.

Agreements
We can create, support, maintain Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), etc.

We also help you with vendor assessment, negotiation, vendor selection, set-up and maintenance of contracts, vendor management.

Pharmacovigilance Audits and Inspections

PV Audits and Inspections
PV Audits:
We have expertise in performing PV audits in all pharmacovigilance areas, your PV System, Local Affiliates, Partners or Service Providers.

Audit Strategy and Planning:
We support creating audit strategic and tactical Plans, and risk-based audit planning.

CSV – Computer System Validation Audits:
We have expertise in Computer System Validation audits for your Safety database system.

Mock-Inspections:
We can support Mock-inspections, i.e. setting up an inspection scenario to practice prior to a real inspection, as well as help you with all the required tasks before, during and after an inspection.

Inspection Readiness:
We can prepare and train you and your PV System to be inspection ready