Background

Real Regulatory Ltd is a consultancy firm specialising in European Regulatory Affairs, Quality Systems, Compliance for medicinal products, medical devices and drug device combination products.

The business was established in January 2002 when the principals Karen Real and Paddy Creed saw the demand for a professional and dedicated regulatory advisory service to assist companies in meeting their regulatory obligations.

Since then Real Regulatory has expanded its team geographically (with offices in Dublin, Ireland, and Cambridgeshire, UK) and in terms of personnel to include individuals at expert level in their core skillsets. Indeed the company is divided into teams of specialists who have the experience to meet client needs in each business area.

The team’s core competency is a strong experience in medicinal product development in Europe.

Team members are actively advising clients on development plans and Clinical Trial strategy, performing due diligence on FDA packages for suitability for Europe, leading Scientific Advice meetings, authoring and review of normative documentation for Competent Authority submissions, orphan drug designation applications and PIPs.

Team members are also actively participating on client project teams and providing hands on support of Clinical Trial submissions throughout the whole of Europe for both Competent Authority and Ethics Committee approvals.

Other strong competencies include quality systems compliance for all healthcare sectors, regulatory maintenance of currently licenced product and provision of state of the art Clinical Evaluation Reports for medical devices.

Quality Systems Compliance Services

This covers accreditation activities for quality systems to various applicable European standards, including:

  • Systems development
  • Document and audit preparation
  • Support during audit
  • Effecting submissions

Client Profiles

Real Regulatory works with companies of all sizes and at all stages of development and across a variety of sectors. Our clients base includes pharma industry, medical device industry, universities, venture capitalists and Clinical Research Organisations (CROs).

Service Delivery

As the business has developed, our service offering has grown, visit Services for a full listing. For some clients we serve as their virtual global regulatory affairs department, while for others we provide more project based support – both offering all the benefits of an in-house team without the logistical demands of accommodating staff.

The key to our success is in consistently bringing the necessary knowledge, skills and expertise to our clients when needed, in Real time.

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