Welcome to Marlow Associates Ltd

Based in the UK we can advise on requirements for development of Investigational Medicinal Product’s (IMP’s) in the EU and US. We offer a wide range of consultancy services, with specialist knowledge of the early phase development for biological and biotechnology based products. We aim to keep clients fully briefed on project progress and will be happy to meet with clients on a regular basis.

The range of consultancy services offered include:

•    Planning and advice on regulatory strategy and applicable legislation.
•    Review and assessment of scientific data for all aspects of product development.
•    Preparation and submission of pre-submission packages for EU and US.
•    Preparation and submission of dossiers for clinical trials in the EU And US.
•    Preparation of Annual Reports and Annual updates.
•    QP support for Investigational Medicinal Products (IMP's) with particular expertise in Biological and Biotechnology products.
•    Support and advice on development of Quality Systems for GLP/GCP/GMP.

 
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