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Consultancy
Preparation of Submissions
Interface with Regulatory Agencies
eCTD
Drug / Device Interface

What we do ...

We provide practical regulatory help and advice to companies who are developing, manufacturing, marketing, licensing or providing active ingredients for products in the pharmaceutical or healthcare sectors.

We deliver high quality services and cost-effective expertise.

We work with client companies of all sizes from large multinationals to small and virtual organisations to help them meet regulatory objectives.

We offer a personal and individual service to move your project forward. You will have the confidence of knowing who is working on your project, and be able to monitor progress and costs whether the project is large or small. We aim to build long term relationships with our clients, and to be the first point of call when regulatory input is required. Much of our work is repeat business.

From regulatory advice to preparation of documents for submissions, we can help you to meet your regulatory objectives. Click on the menu on the left to view more information about the services we offer.

For small and early stage companies we are pleased to provide regulatory intelligence to establish the regulatory environment for new technologies and can also offer mentoring and support where companies are taking on their first employees in a regulatory or QA role.

For larger companies we can work to support your own regulatory department and project teams

For companies based outside the EU we can work with you to review dossiers for EU suitability.

For Active Pharmaceutical Ingredient manufacturers we can help with Master Files and EDQM Certificates of Suitability.

Please call us or email to discuss your particular requirements. We will always be pleased to hear from you and to answer any questions you may have.

Linda Rawlings
Telephone +44 (0)1751 417765
Email: linda@empatec.com