PharmAdvice
PharmAdvice is an independent Danish consultancy company specializing in helping customers in the pharmaceutical industry. Since 2002, they have been providing expertise and deep knowledge in regulatory requirements, pharmacovigilance, regulatory affairs, marketing support, and quality compliance. Their mission is to add core value to their customers through experience, knowledge, dedication, and commitment, ensuring compliance and simplifying complex legal and regulatory material.
Industries
Nr. of Employees
small (1-50)
PharmAdvice
Services
Contracted PV services including adverse event intake and case processing, expedited and periodic reporting (PSURs/PSRs), PSMF maintenance, SOP governance, PV training, and QPPV support.
Regulatory strategy, preparation and submission of marketing authorisation applications and renewals, lifecycle management, and eCTD dossier preparation.
Provision of external Responsible Person services, GDP and supplier qualification audits, participation in joint third-party audits, and QMS self-inspections.
Risk-based audits of PV systems and subcontractors, audit preparation and follow-up, and review/development of business continuity plans for PV operations.
Contracted PV services including adverse event intake and case processing, expedited and periodic reporting (PSURs/PSRs), PSMF maintenance, SOP governance, PV training, and QPPV support.
Regulatory strategy, preparation and submission of marketing authorisation applications and renewals, lifecycle management, and eCTD dossier preparation.
Provision of external Responsible Person services, GDP and supplier qualification audits, participation in joint third-party audits, and QMS self-inspections.
Risk-based audits of PV systems and subcontractors, audit preparation and follow-up, and review/development of business continuity plans for PV operations.
Expertise Areas
- Pharmacovigilance and safety surveillance
- Regulatory affairs and marketing authorisation lifecycle management
- Electronic regulatory submissions (eCTD) and regulatory data management
- Marketing compliance and promotional oversight
Key Technologies
- Electronic Common Technical Document (eCTD) submissions
- Pharmacovigilance and safety databases
- Signal detection and signal management systems
- Regulatory registries management (OMS / EudraGMDP / Article 57-type registries)
News & Updates
Business Continuity Risks
Review of the pharmacovigilance business continuity plan (BCP) to ensure alignment with relevant risks and threats.
EcoVadis Sustainability Rating: Committed
In January 2025, PharmAdvice achieved a 'Committed' rating in their first EcoVadis sustainability assessment with a score of 57 out of 100.
Guide: What documentation to send to your PV consultants in 2025
A list of ongoing and annual pharmacovigilance activities and the documentation needed for each.
Risk-based audits of pharmacovigilance service providers
Guidance on the steps to conduct risk-based audits covering governance, risk management, and internal controls.
Extension of pilot period for MAH requirements
EMA's extension of the pilot for monitoring EudraVigilance data until the end of 2023 for certain active substances.
A new medical product - but for how long?
Guidance on the limited period for using the term 'new' for medicinal products, defined as 1 year from first marketing.
Business Continuity Risks
Review of the pharmacovigilance business continuity plan (BCP) to ensure alignment with relevant risks and threats.
EcoVadis Sustainability Rating: Committed
In January 2025, PharmAdvice achieved a 'Committed' rating in their first EcoVadis sustainability assessment with a score of 57 out of 100.
Guide: What documentation to send to your PV consultants in 2025
A list of ongoing and annual pharmacovigilance activities and the documentation needed for each.
Risk-based audits of pharmacovigilance service providers
Guidance on the steps to conduct risk-based audits covering governance, risk management, and internal controls.
Extension of pilot period for MAH requirements
EMA's extension of the pilot for monitoring EudraVigilance data until the end of 2023 for certain active substances.
A new medical product - but for how long?
Guidance on the limited period for using the term 'new' for medicinal products, defined as 1 year from first marketing.