Clinical Trial Regulatory Consulting
Real Regulatory can provide you with the expert regulatory strategy to effectively manage your clinical trials across Europe and around the world. We can guide you through the journey to regulatory approval and beyond. Our extensive knowledge extends from in-depth know-how on the requirements of regulatory authorities around the world, to the requirements of specialized therapeutic areas, and to the specific issues that affect each application to reach the regulatory green light to give your clinical trial the best possible start.
At Real Regulatory, our experienced team will drive your clinical trial regulatory requirements and will respond to your specific needs, whether that is a phase I, single site study or a phase III global, multi-centred mega-trial.
Our Clinical Trial Regulatory Consulting services include:
- Advice on regulatory submission strategies during all stages of your clinical development plan
- Advice on country-specific regulatory requirements
- Strategic advice and preparation of key submission documents, such as the Investigator Brochure (IB), Investigational Medicinal Product Dossier (IMPD) and protocols
- Review data generated in support of an application in compliance with regulatory requirements
- Review of sponsor-prepared documents
- Preparation and submission of your Clinical Trial Application submissions in compliance with regulations and guidelines
- Interaction with regulatory agencies to seek advice, agreement, and approval of your trial
- Management of communications between the regulatory agencies and the sponsor or legal representative
- Provision of issue-focused regulatory support throughout your trial
- Advice on and provision of trial maintenance activities including amendments, notifications and end of trial tasks