Although the requirements imposed by national health system legislation and regulatory authorities place a growing strain on  Life sciences industry, we can help you use IT to comply with new and upcoming regulations and at the same time increase efficiency. By restructuring processes, introducing best of the breed solutions and deploying IT more efficiently, you can achieve a more dynamic flow in your business.

Implementing regulatory document management solutions based on our partner NextDocs validated Microsoft SharePoint platform lets you meet regulatory requirements and improve collaboration between the various departments involved, for example in e-submissions. This means you can get products to market faster while staying in full compliance with all relevant requirements. We also offer smaller footprint solutions for regulatory document management that allow improved collaboration

Improve integration and process quality
We have experience with all aspects of drug regulatory affairs and offer a range of services from integrating regulatory planning to tracking information with regulatory documents and product submissions, for example in order to fulfil the upcoming IDMP standards of the European Health Authority EMA (including the necessary submission of registered medicinal products as of July 2011 in a format similar to an extended EVMPD). We also are able to support you in setting up global labelling solutions including the integration of the label translation, artwork supply chain and SPL submission processes.

Other services include:

• Advice on regulatory affairs in all aspects of the value chain
• Guidance on how to optimise business processes while remaining compliant
• Identification and interpretation of the relevant regulatory requirements
• Selection and implementation of solutions for regulatory document management, regulatory planning and tracking as well as global labelling
• GxP validation and alignment of IT systems with relevant regulations, such as 21 CFR Part 11
• Monitoring of regulatory requirements and help preparing for inspections