Services
Our services
- Our services help our clients understand, observe and maximise the regulatory environment, smoothing the path to Marketing Authorisation Approval.
Full Dynamic Regulatory Strategy including all relevant advice and services including:
- Scientific/Protocol Advice Procedures
- Orphan Drug Applications, including joint FDA-EMA procedures
- Regulatory and Medical Writing including Dossier Preparation
- Development of Investigational Medicinal Product Dossier (IMPD),
Investigator’s Brochure (IB), Paediatric Investigation Plan (PIP) - Regulatory Submissions Management
Regulatory On Call:
- Answers to your ad hoc regulatory questions at the end of the phone or by email
- Quick turnaround regulatory advice & consultancy as and when required
- Managed via a monthly retainer fee
EU /UK Representation for non-EU/UK sponsors of Clinical Trials:
- Clinical Trial Legal Representation
- SME Initiative Representation
- Orphan Drug Designation Representation
What our clients say about us:
From reach out to project set up, through periodic updates the whole process went very smoothly. Our communications with the team were proportionate, appropriate and helpful. We would definitely use them again should the need arise. Program Manager, Rare Diseases biotech company
I have used IDEA Regulatory for more than a decade for EU legal representation services. Quite simply, I cannot imagine working with anyone else. They are highly competent, extra dedicated and the team comprises those rare individuals that simply have the ability to improve your day! Manager, Regulatory Affairs Operations, Drug Discovery and Development Company
What I love, is that you never have to wonder. The appropriate information is there. They back everything up with up-to-date guidance to hand if needed. I also feel they have been great mentors in this space. I have learned so much from them. Manager, Rare Diseases Drug Discovery and Development Company
The set up and contract negotiations were smooth and easy and communication was regular and proportionate. I have since used IDEA Regulatory again on another trial and will continue to do so on the back of this positive experience. Associate Director Clinical Trials, Oncology Biotechnology Company
