Our drug development experts have international industry experience and competences that increase the value of your development projects. With realistic assessment of data and regulatory requirements we can create the best possible development and lifecycle management plans that help bring products into the market and maintain them.


Areas of expertise

Our drug development experts have hands-on experience in the pharmaceutical industry and with medical device companies. We offer guidance and documentation services in most drug development disciplines across a broad range of therapeutic areas.

Our expertise includes:

  • Product development strategies and plans (overall, clinical, preclinical, CMC, regulatory)
  • Documents for regulatory purposes (efficacy, safety, quality)
  • Documents for planning and decision-making (project plans, TPPs, risk assessments, gap analyses, second opinions)
  • Scientific advice/pre-IND (LoQ, briefing documents, facilitate meetings with authorities)
  • Due diligence of projects and portfolios
  • Interim experts (medical, clinical, preclinical, CMC, QA, biostatistics and regulatory)
  • Interim project management, alliance management and R&D management.

Therapeutic areas

Our drug development counselling experts have significant experience in:

  • Cardiology
  • Diabetes
  • Gastroenterology
  • Haematology
  • Immunology
  • Infectious diseases
  • Oncology
  • Neurology
  • Psychiatry
  • Respiratory 
  • Pain

Geographical coverage

Drug and medical device development plans usually target an international market. While most of our clients develop their products for Europe and the U.S., there is a growing demand for support with regulatory approvals and lifecycle management for other markets.

Our drug development counselling experts have much experience in interacting with authorities in Europe, including Russia/CIS (EMA, national agencies and notified bodies), the U.S. (FDA) and Japan (PDMA). We also cover other authorities and markets through collaboration partners.

  • Michael Engsig

    Michael Engsig
    (MSc Biotech, GDBA)

    EVP Drug Development Counselling & Business Development

    T: +45 44 222 913
    E:

Drug Development Counselling Consultants: