Pharma, medical device, and biotechnology companies, especially emerging companies, face critical strategic, operational and regulatory challenges, stiff competition and rising customer expectations.
CROMSOURCE leverages 20 years of drug and device development experience to provide a broad range of consultancy services. CROMSOURCE Consulting Services works with clients to develop comprehensive and customized solutions to optimize product development, minimize costs and time to market for novel therapies and medical devices.
By engaging CROMSOURCE, clients gain a flexible and attentive mid-size partner with experts who can address their needs directly. We will assemble and co-ordinate a highly responsive team of cross-discipline professionals ready to assist with a wide range of expertise, in areas such as clinical pharmacology, clinical development, biometrics, regulatory affairs, medical writing, compliance, information technology, and corporate strategy and finance. With offices in Europe and the USA, CROMSOURCE can advise on overall development plans, or on targeted strategy from early stage to marketing approval/clearance through life-cycle management.
CROMSOURCE can also call on its wider scientific, medical and regulatory external expert network in specialized areas. Ongoing interactions with key scientific and medical experts and opinion leaders ensure that CROMSOURCE is up-to-date with high-level knowledge of current trends in research and drug/device development. Our well-established connections with key regulatory experts permit us to identify the best regulatory strategy for our clients.
As a full service CRO, CROMSOURCE can assist our clients in optimizing scientific, clinical and regulatory product development strategies, in addition to executing these clinical plans and assisting with regulatory submissions.
- Changes to EU Medical Device Legislation: What you need to know - White Paper June 2016
- Clinical Data for Medical Devices - Preparing for increased requirements in the EU - White Paper, 2015
- Medical Device Overview
- Clinical Evaluation Reports - White Paper, 2015
- Wound Closure - White Paper, 2014
- EU Recast of the Medical Device Directives: The Rocky Road to the new Medical Device Regulation - White Paper, 2014
- Language Requirements for EU Medical Device Labels - Multilingual, September 2012