We offer a variety of first-class services for the pharmaceutical industry in the EU.

We can assist you with a specific task or provide a permanent or long-term solution in our core areas of expertise: Regulatory Affairs, Pharmacovigilance, Contract Manufacturing, Clinical Trial Supply and QA/QP Services

Regulatory Affairs

Our experienced regulatory troubleshooters can assist in all regulatory affairs activities according to the requirements of the European Medicines Agency (EMA) and the national EU competent authorities such as:

  • Regulatory strategies
  • Marketing authorisation applications
  • Submissions in eCTD format for all procedure types (CP, DCP/MRP and National)
  • Life-cycle management
  • SmPC and labelling documents
  • Regulatory review of promotional material

Pharmacovigilance

We offer pharmacovigilance services for marketing authorisations for human and veterinary medicinal products in the EU. Our pharmacovigilance services include, e.g.:

  • EU QPPV and local QPPV
  • Registration in Eudravigilance
  • Reporting of adverse events (AEs) and management of AE reports
  • Literature surveillance and signal detection
  • Pharmacovigilance System Master File (PSMF)
  • Preparation of risk management plans (RMPs) and PBRER
  • Quality system audit and inspection support

Contract Manufacturing

We conduct manufacturing of liquids and semi-solid dosage forms including creams, ointments and gels. Furthermore, we handle powders and suspensions and various medical devices.

  • Product Development
  • Manufacturing
  • Packaging
  • GMP facilities
    • Clean room for manufacturing of oral, nasal, topical use, etc.
    • Equipment for filling liquids, gels, etc.
    • Packaging area, repackaging, labelling, manual packaging
    • Cold and freeze storage with 24 hours surveillance
    • 24/7 emergency hotline
    • 24-hour video area surveillance

Clinical Trial Supply

We carry out GMP Manufacturing, packaging, labelling and worldwide distribution of clinical trials supplies. We are a flexible and reliable provider of clinical trials supply services from pre-clinical through all clinical phases.

  • Project Management
  • Sourcing of comparator medication
  • IMP and API import from 3rd country
  • Bulk manufacture of IMPs and placebo products
  • Creation of randomization lists and printing of emergency letters
  • Blinding of all dosage forms depending on study requirements
  • De-packaging of commercial products
  • Primary and secondary packaging
  • Label and material design
  • Storage and distribution
  • Return, reconciliation and destruction of study materials

QA/QP Services

Our QA professionals are specialized in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Good Clinical Practice (GCP).

  • Support for GMP/GDP
  • Quality systems for GMP/GDP
  • Audits
  • Training

Authorisations

Nord Pharma Partners has maintained authorisations from the Danish Medicines Agency for manufacturing of human and veterinary medicinal products since 2003.

 

  • §39, Human and Veterinary
  • Certificate of GMP compliance, Human
  • Certificate of GMP Compliance, Veterinary
  • Certificate of GMP compliance, IMP

 

Authorisations from the Danish Veterinary and Food

Administration has been maintained since 2003