Regulatory Review
Consolida market assessment, regulatory strategy and commercialisation consultancy for the biomedical and life sciences sector
We use our knowledge of the EU and US regulatory systems to:
Map out product development plans for novel medical products;
Estimate the cost and duration of activities required to gain approval to market products;
Assess the regulatory status of 'borderline' products;
Conduct systematic clinical literature reviews for regulatory submissions:
For CE marking of medical devices;
For compilation of Common Technical Document (CTD), for pharmaceutical products
"Since the start of Consolida, Gill and I have worked together on several projects a process that I always find educative and stimulating. She has a combination of talents that is rare – a mind that is always searching but remains focussed on the objective while leaving no stone unturned; an engaging telephone survey manner that somehow seems to extract that last nugget of information and leave the respondent feeling pleased that he/she could help; and last but not least, a facility for sifting and synthesising the information obtained and presenting it in a concise, structured, highly readable report. I cannot commend her too highly." Dr. Iain Colquhoun, Director, Medeco Limited.
