Regulatory Compliance Outsourcing

In today’s fast-changing and increasingly complex regulatory environment, many companies are choosing to outsource pharmaceutical regulatory affairs and quality assurance in order to ensure compliance.

 

Tasks relating to regulatory affairs are often the responsibility of staff members who do not have the necessary knowledge or experience to complete them. As a result, these matters may not be given the time and attention they require.

 

APT Transtelex’s medical division can offer a regulatory compliance service which covers every aspect of pharmaceutical production from manufacturing processes through to labelling and instructions for use, ensuring they comply with national and international standards such as those required by European Medicines Agency or the US Food and Drug Administration.

 

In order to sell in international markets, companies must fulfil extensive linguistic requirements in order to comply with current legislation. This means documentation must be accurately translated into the relevant target language(s) for each market.

 

Working with a global network of over two thousand regulatory affairs specialists, our medical division is able to offer help and advice at each stage of a product’s life cycle, from the early stages of development through to the product’s launch.

An experienced translation partner with proven specialist knowledge in pharmaceutical regulatory affairs is essential to the complete success of your projects.

APT Transtelex offers a full range of regulatory affairs and translation services including:

• Support for clinical trials which are conducted on a global basis, provided by specialists dedicated to linguistic validation of the related documentation.
• Translation of all types of printed and electronic pharmaceutical documentation, including informed consent forms, labels, package inserts and instructions for use.

Contact us to find out how APT Transtelex helps pharmaceutical, biotechnology and healthcare organisations reach their objectives by offering flexible integrated solutions on a global scale.