Clinical Trial Regulatory Consulting

By: Real Regulatory  05/12/2011
Keywords: Clinical Trial

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

Keywords: Clinical Trial

Other products and services from Real Regulatory


Regulatory Quality Assurance - Regulatory Compliance

Develop and implement an ISO 13485:2003 or ISO 9001:2008 quality management system (or parts thereof) including CMDCAS. Conducting pre-inspection audits to assess readiness for quality management system certification/registration. Conducting audits on behalf of client companies (supplier audits / internal audits.


Cosmetic Regulatory Legislation - Food Supplement Classification

Review of clinical studies to document safety of ingredients, and to substantiate label claims. Classification of cosmetics products and cosmetics justifications for borderline products. Interpretation of guidance and legislation, as they relate to products or practices. Reviewing food supplement labels/advertising for compliance with regulations. Liaison with the competent authorities on behalf of our clients.


Pharmaceutical Regulatory Affairs

Preparation, submission and follow up of Scientific Advice and Orphan Drug Designations. Preparation and submission of Marketing Authorisation Applications. Submission and follow up of Paediatric Investigations Plans. Variations Type I, Type II and urgent safety restrictions. Submission and follow up of clinical trial applications. Performance of PIL user testing.


Pharma Regulatory Affairs

We have capabilities across the spectrum, that allow us to deliver most requirements – they include all the procedures that relate to the life cycle of NCEs, devices and diagnostics, known compounds, and Quality Assurance matters, amongst others. There are a wide number of regulatory affairs activities that might be needed across the pharma and related industry sectors where Real Regulatory has expertise.


Medical Devices Consulting - ISO 13485 Audit

Auditing of Quality & Regulatory system to ensure compliance with required quality systems & regulations. Preparation and submission of registration for product applications. Provide medical device classification and pre-market strategy. Liaisons with EU Competent Authorities and Notified Bodies. Regulatory and Technical review and consulting. Medical device vigilance and reporting systems. Pre-/post-inspection audits to ISO 9001:2008.