ArrayDiagnostica
Make science into business
Copyright © 2007 - ArrayDiagnostica - Skovvejgaard, Skovvejen 13, DK-4660 +45 56508812
BIOTECH & PHARMA CONSULTANCY
Due Dilligence:
Review of product portfolio
- Defining the risk profile
- Bio functionality study
- Drug carrier
- Drug portfolio
- Therapeutically analysis
- Preclinical risk assessment
- Clinical risk assessment
- Regulatory risk assesment
- Marketing potential
Regulatory evaluation
A regulatory strategy is vital for the devise/ study drug program
Needs to be performed at the beginning of a project
Includes:
Pre IND meetings with FDA and EMEA regulatory advice meetings
Full or partly EMEA or FDA IND filling and other regulatory supports
Regulatory support on specific country information, timelines for EC/ US filing etc
Is there a plan?
Clinical program
The clinical study plan has to reflect the regulatory plan:
Study program from NCE to NDA
How to design for regulatory approval/ reimbursement?
Concept studies to raise value?
Special studies regarding abuse, risk management, pharmacovigilance etc
Market potential
Full or semi market analysis country or global based
Analysis of products in the clinical pipeline related to specific therapeutically or bio functional aspects
Health economy/ reimbursement
Advisory boards
We can participate as full member or partly consultancy member on advisory boards covering some of the above issues
We can also suggest members or arrange advisory boards in specific treatment areas
Careers
- CTA in international team, Denmark
- 2 International Study Managers
- Lead CRA, Denmark
- International Study Manager, Stockholm
- GCP Manager/Project Manager, Stockholm