ABOUT US
With over 20 years' experience providing consulting services to leading global organisations we have unique delivery capabilities.
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Core competency within life science regulation gained from our work with the European Medicines Agency and industry developing practical solutions for IDMP compliance. Our team brings together a unique understanding of regulatory strategy and technology to deliver solutions that ensure compliance whilst enhancing your operational efficiency.
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We work with you to understand your objectives and agree a delivery framework based on a detailed implementation roadmap ensuring transparency throughout the project lifecycle. Our approach is unique and ensures you always remain in control and have flexibility to re-focus should your organisation's priorities evolve mid-project.
The regulatory domain is complex and heavily reliant on documents. Despite the emergence of global standards such as IDMP, this is not changing anytime soon. The frequent talk of migrating from document driven processes to data driven processes is mis-leading as this implies a reduction in document submissions which, unfortunately, will only happen slowly. Rather, the burden on industry will increase - data submissions will be an additional workload - BUT, this doesn't need to be all about compliance! With the right strategy you can develop an infrastructure to support data submissions requirements across multiple jurisdictions AND make this data available for re-use across your organisation. This is not easy but it is achievable and you will reap the rewards of an integrated strategy for product data management.