Regulatory Support Services
IDMP
Identification of Medical Product (IDMP) is a significant data standardisation challenge for pharmaceutical companies, aiming at a unique identification of medicinal products. European Medicines Agency (EMA) is the first of those who decided to mandatorily adopt these new ISO standards. Meaning that after a regional deadline (year 2022), all pharmaceutical companies operating in the European Union must comply with IDMP regulations. Other regions (including the United States and Japan) are expected to provide their deadlines gradually. Although timelines for IDMP implementation have been shifted, it is inevitably coming to the final stage as EMA is currently finalising guidelines, to be released in 2020. For those who have not launched their IDMP projects yet, or are at the initial stage, this is the right time to mobilise. Staying idle is not an option.
We support our clients in their efforts to unlock the power of product data thanks to IDMP, and transform their business and improve patient health by:
- Understanding IDMP, its impact and benefits specific for your organisation
- Setting up a short/long-term strategy
- Mapping all the resource systems and data
- Implementing solution fitting your business needs
- Supporting at maintenance
Our experience with master data management alignment and the implementation of EFPIA HCP/O transparency reporting regulations showed a reduction in program and operational issues related to key master data as well as ensuring that regulatory requirements are met. Even greater potential now lies within the building blocks of IDMP standards.
Support of Registration Management
We understand that the regulatory environment is complex enough, and we are continuously striving to find solutions for the purposes of simplification and effectiveness. Registration-related fees have a significant impact on the planning and financial lifecycle of each product.
We can help you to:
- Consolidate input from different regulatory sources across countries to ensure their up-to-date overview and reduce manual workload;
- Monitor & maintain the whole regulatory budget so you can quickly react to changes;
- Easily explore & compare options to determine the most suitable registration strategy.
Requirements that registration documents are of a higher quality are increasing, and thus companies should thoroughly deal with deficiency letters from regulators in order to minimise prolonging timelines or to avoid withdrawal of registration.
We can help you to:
- Forward all deficiencies received or comments from regulatory authorities to a database and to utilise the lessons learned to become more efficient;
- Connect to a powerful analytical tool to perform evaluations and generate customised visualisations and dashboards providing meaningful insights.