PharmAdvice is specialised in the fields of Pharmacovigilance, Regulatory Affairs and Marketing Support and Compliance.
Since 2002 PharmAdvice has been working as an independent Danish consultancy company, helping start-ups, ongoing businesses and multinational companies in the pharmaceutical industry getting products to the Scandinavian market.
We are a dedicated and experienced team offering pharmacovigilance services for marketing authorisations, for both human and veterinary medicinal products in the EU.
Our pharmacovigilance services include:
- EU QPPV and 24-hour availability
- Registration in Eudravigilance
- Reporting of adverse events (AEs) and management of AE reports
- Literature surveillance and signal detection
- Preparation of risk management plans (RMPs) and PSURs
- Support and participation during pharmacovigilance inspections
Marketing Authorisation applications for medicinal products require both expertise and diligence to ensure that the requirements of the European Medicines Agency (EMA) and the national EU competent authorities are met.
Our experienced regulatory troubleshooters can assist in all regulatory affairs activities such as:
- Regulatory strategies
- Marketing authorisation applications
- Submissions in eCTD format for all procedure types (CP, DCP/MRP and National)
- Life-cycle management
Marketing Support and Compliance
A detailed understanding of the current regulations and codes of ethics is a must when it comes to promoting medicinal products in Europe. At PharmAdvice we can provide professional guidance regarding:
- Communication and advertising to the public as well as Health Care Professionals (HCPs)
- Professional meetings, gifts, sponsorships and representation
- The use of eHealth as a marketing tool
- Compulsory product information
- SmPC and labelling documents