About

Real Regulatory Ltd is a consultancy firm specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance.

The business was established in January 2002 when Karen Real and Paddy Creed saw the demand for a professional and dedicated regulatory advisory service to assist companies in meeting their regulatory obligations. A key focus, historically, was helping businesses to gain approval for their medicinal product marketing authorisation applications, renewals and variations.

Since then Real Regulatory has expanded its team to include individuals with substantial experience in the regulatory aspects of clinical development, Quality Management Systems compliance and Regulatory Affairs for medical devices, veterinary medicinal products and drug-device combination products.

The company is divided into teams of specialists who have the necessary experience and expertise to meet client needs in each business area.

Regulatory Services cover the requirements of these diverse product types, throughout their lifecycle, including:

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

Quality Management 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 also now include universities, venture capitalists, Clinical Research Organisations (CROs), natural health product manufacturers and food companies.

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 global regulatory affairs department, while for others we provide temporary in-house staff assistance. We can also offer a Virtual Regulatory Department service – 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.

Talk to us about your goals and how we can help you achieve them