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The download centre is TRAC's regulatory information hub. You'll find more detailed information on some of the services we offer as well as general news and industry articles written by the TRAC Regulatory Team. We're constantly updating the centre so please feel free to keep visiting to see what's new.
Our Download Centre has been created to make it as easy as possible for you to find the information you want.
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To download most of the documents from our Download Centre you will need to register and create an account. This is very easy to do and simply requires your full name and a valid e-mail address.
Once you have successfully logged in you will be able to access all of the documents within our Download Centre by clicking on the relevant link.
Should you experience any problems using the Download Centre please e-mail us at info@tracservices.co.uk and we will deal with your query quickly and efficiently.
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EU New Variations - one year on
Graham Donaldson, Senior Regulatory Executive at TRAC, reviews a recent seminar he attended by the MHRA (Medicines and Healthcare products Regulatory Agency) to review the implementation of new variation regulations.
It provides a valuable insight into assessors' experiences highlighting key issues plus some practical guidance going forward.
Embracing eCTD and Lifecycle Management
TRAC's Senior Regulatory Executive, Lisa Pascoe reviews the benefits and challenges of eCTD and lifecycle management one year after the EMA (European Medicines Agency) made this format a mandatory requirement for all submission types.
The Evolving Role of European Regulatory Agencies
In this article Matthew Walker, Senior Regulatory Affairs Executive at TRAC gives an overview of the discussions that took place at the recent joint meeting between The Organisation for Professionals in Regulatory Affairs (TOPRA) and the European Medicines Agency (EMA).
The meeting explored the future role of the Regulatory Agencies and the potential ways they could continue to work with the pharmaceutical industry and patient groups to safeguard public health.
Orphan Drugs
Orphan medicinal products are used to diagnose, treat and prevent rare diseases. In 2000 the European Union (EU) implemented the Orphan Drug Regulation (EC) No 141/2000 to promote research and development of orphan medicines in the EU. This report provides a brief overview of orphan drugs as well as an explanation of the application process to obtain orphan designation.
Counterfeit Products and the Safety Profiles of Genuine Medicines
We’ve read numerous articles recently regarding the global rise in counterfeit medicines, the proposed measures to help combat the problem and the cost to the pharmaceutical manufacturers’. However, to date there has been little discussion regarding the impact of these products on safety data.
In this article Sophie Hobson, Pharmacovigilance Manager, attempts to address this and highlights the issues the industry needs to consider.
Reshaping the UK Research & Development Landscape
A look at the recent changes the Big Pharma's are making in their approach to Research & Development (R&D) specifically looking at the impact on the UK pharmaceutical industry. Company director, Jonathan Trethowan wrote this article for Pharmafile's Research & Development Guide published in November 2010.
Medical Device Regulations
Like Medicines, before a medical device can be sold on the European market it is necessary that the product meets the required standards of safety, quality and efficacy and thereby can carry the CE mark.
Paediatric Pharmaceuticals
An introduction to the challenges and benefits in the area of paediatric pharmaceuticals including the requirements of the Paediatric Regulation No.1901/2006, Paediatric Investigation Plans and the incentives invovled.
eCTD
eCTD (electronic Common Technical Document) is increasingly becoming the preferred method of submission of regulatory information. This guide has been designed to help you understand the requirements and assess the benefits of this fast developing new method of submission.
Marketing Authorisations
To help you understand the various routes to market that are available and decide which the best option for your product we have produced a document that covers all aspects of Marketing Authorisation Applications.
Pharmacovigilance
Pharmacovigilance is central in every product’s life cycle, from development to post-approval. This paper provides information concerning the role of Pharmacovigilance in your product’s life cycle.
PIL Testing
This is an informative guide to all aspects of PIL User Testing.
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