MA Centre™: Marketing Authorisation management
MA Centre™ is a powerful web-based database system that tracks and stores information about all of a company's Marketing Authorisations (MAs) and all the activities that may occur during a product's lifecycle:
- Clinical trials
- Applications for licences, variations (amendments in the US) and renewals
- Safety reviews and internal quality control
- Questions from authorities
- Packaging, manufacturers and suppliers
This information constitutes the definitive statement of the products that a company is allowed to sell.
Successful management of MAs is one of the main business challenges facing pharmaceutical companies
Any deviation from MAs - or failure to update them accurately, completely, and in time - can lead to product withdrawal, stock wastage, lawsuits or fines for regulatory infringements. Any of these can lead to a serious impact on public confidence, sales and corporate share price.
This means that successful management of MAs is one of the main business challenges facing pharmaceutical companies - regulatory compliance and strategy, successful audits, partnerships, product development and safety, manufacturing, resource planning, advertising, marketing and selling all depend on it.
MA Centre™ enables companies to co-ordinate and manage these overlapping processes to satisfy often multiple regulatory bodies, ensuring that work is begun and completed on time, and to the correct specification. No activity or deadline need be overlooked and information is shared at a number of different levels across the operation, with secure access for different users:
- For regulatory professionals using the system every day, the system provides forms and tools to store and retrieve MA information, record and track renewals, applications and variations and to flag important dates (with the option of e-mail alerting)
- At a departmental level, MA Centre™ enables consistency in working practices and provides a central store of reference materials
- For management, MA Centre™ provides planning tools, metrics and graphs on performance
MA Centre™ flexibly incorporates changes in working practice and absorbs regulatory changes when they occur, with minimal reconfiguration. It can also facilitate links with other deparments and in-house systems (e.g. Documentum), where specific tasks will normally be carried out.
Launched as Register! in 1997, with a web version following in 2003, customers over the years include Pharmacia, Janssen-Cilag, Eisai, Bayer, Norgine and Amersham Health.
Please contact us for more information.