About

Background

Real Generics Ltd is a consultancy firm specialising in European Regulatory Affairs and Regulatory Compliance for the generic pharmaceutical industry.

The business was established in April 2015 when Karen Real (Director) and Paddy Creed (Managing Director), saw the requirement for a professional and dedicated regulatory advisory service to assist generic companies in meeting their regulatory obligations.

Real Generics Ltd is a member of the Real Regulatory Group. The partner company, Real Regulatory Ltd, is a consultancy firm specialising in European Regulatory Affairs, Quality Management Systems and Supply Chain Operations Compliance for the pharmaceutical, medical device and aligned industries.

Real Regulatory is also run by Karen Real and Paddy Creed. Therefore, the directors have a strong track record in providing high quality consultancy to the marketplace.

Real Generics is managed and driven by Michelle Gafa, Managing Consultant, a pharmacist who has almost 20 years’ experience in the generic pharmaceutical industry. Michelle is supported by a team of specialists who have the necessary experience and expertise to meet client needs.

Regulatory Services cover the requirements of generic products throughout their lifecycle, including:

Strategy and development
Effecting submissions
Gaining approvals
Post marketing lifecycle management

The services are underpinned by an internal quality system which has been built in accordance with ISO 9001:2008 requirements. All activities are process mapped from initiation of the project right through to completion.

Client Profiles

Real Generics Ltd works with companies of all sizes and at all stages of development.

Service Delivery

For some clients, we serve as their global regulatory affairs department, while for others we provide support for discrete projects and activities. 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.

Flowchart-Real-Generics-v2-600x