Services
Regulatory Affairs
and scientific advice
Harrison Clinical Research has an international scientific advisory board comprised of established specialists from different countries and different medical areas. This ensures that clinical studies are performed according to the latest medical thinking and that the best approach to obtaining marketing approval is made.
Our services include recommendations on studies to optimise the registration dossier, including evaluation of existing data. Preparation and submission of registration dossiers can be undertaken and meetings with regulatory authorities can be arranged as part of our services.
Together with our associated company Verius Ltd, a drug and healthcare product development service company based in Cambridge, UK, our regulatory affairs services cover all stages of drug development and encompass manufacturing and quality, non-clinical and clinical aspects. We can assist with new and existing synthetic molecules, biologicals and novel technologies and devices. We are fully compliant with ICH requirements and guidelines and cooperate with all major regional and national regulatory agencies in Europe, North America, Japan and elsewhere.
Sponsor's not established in the EU are required to submit trials through a legal representative in the EU. There are many obligations for sponsor's including reporting to ECs and CAs and adverse event recording and reporting. I.D.E.A. Ltd satisfies the need that the sponsor must be established in the EU by acting as legal representative. They can also provide means and capabilities to perform your trial in Europe without the need for your investment in offices or other resources. I.D.E.A. Ltd can fulfill all these requirements in a speedy and effective manner.
We use the Common Technical Document (CTD) format and can also adapt existing documents to this format. Using an industry standard, fully validated safety database system, we can provide pharmacovigilance expertise at any stage of development.
For further details see
Feel free to phone us
...straight away and we will work out together a tailor made solution for you.
Tel: (49) - 89 - 126680-0
Videos
Gold Award to
Harrison Clinical Research
Presentation to HCR, by Lloyd's Register Quality Assurance (LRQA) of the Gold Award for more than 10 years of certified compliance with ISO 9001 standards.