Drug Development Counselling
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.
- GCP Audits - site and CRO/Vendor audits. Support to optimizing your GCP Quality Management System.
Our drug development counselling experts have significant experience in:
- Infectious diseases
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.
(MSc Biotech, GDBA)
EVP Drug Development Counselling & Business Development
T: +45 44 222 913
Drug Development Counselling Consultants:
Medical Advice and Clinical Development
CMC and Preclinical Development
- Anders Vagnø Pedersen
- Anders Christensen
- Kim Hejnaes
- Steen Gyldendal-Melberg
- Jørgen Lang Pedersen
- Anke Domdey
- Jørn Arnt
- Lars Mecklenburg
- Martin Munk
- Jens Bukrinski
- Jes Jacobsen
- Simon Bjerregaard
Regulatory, QA, Patents, Statistics, Medical Writing
- Ira Hartling
- Hanne Jensen
- Tina Kjøller
- Roger Timewell
- Elisabeth Augustsson
- Tine Kronborg-Hansen
- Lars Bo Kjerrumgaard
- Bjarne Bodin
- Peter Bergqvist