Regulatory Affairs Systems

Home / Solutions / Regulatory Affairs Systems

Compile Your Medicinal Product Data to comply with the New ISO IDMP Standard

ISO IDMP Standard is soon set to replace XEVMPD Standard to identify medicinal product information using SPOR data management services. This change is expected to improve information exchange between various stakeholders in medicinal product development namely – company, sponsors, regulatory agency, and data sources. By enabling coordination between these stakeholders it would result in interoperability and harmonization, a long sought motive by both global regulators and industry bodies.

Without a doubt, the change of standard will help cover product attributes at various stages of the product life cycle, and will also allow for transparency & traceability. But the resultant cost could prove expensive for sponsors to manage. Moreover, the newly compiled data will again be reviewed and approved as part of submission cycle denoting the need to revisit the compliance strategy and guidelines all of which entails rework of end-to-end data management services.

Amidst the evolving regulatory scenario, the onus lies on pharmaceutical and life sciences companies to quickly enable high quality data elicitation from the all levels within the organization pertaining to the product while balancing both timelines and revenue. In such a scenario, Techsol can prove to be a reliable partner who brings the right blend of deep regulatory domain expertise and technology knowledge to build solutions that address the challenge of complying with the latest ISO IDMP standards at an optimal cost.

How We Help Clients

As a pioneering service partner for regulatory operations, Techsol is optimally suited to help interpret the guidance and its revisions, and address various challenges you might face en route aligning with the new ISO IDMP standard. To that end, we provide systematic and flawless IDMP consulting services for our clients. Listed here are the core competencies pertaining to our service.

  • IDMP Assessment
  • Accurate and current status reports and analytics with high level of data integrity
  • Data Consideration Factors:
    • Accessibility
    • Precision
    • Complete
    • Unique
  • Data management strategy and implementation approach
  • Gap analysis and recommendations that enable first-time-right IDMP implementation
  • Process expertise that enables phasing out of technology solutions (hosted or on-premise)
  • Cost-effective and time-bound performance

Our Expertise:

  • Well-organized and strategically assembled implementation IDMP
  • Distinctly mapped IDMP baseline creation
  • Support to identify source, organize and conduct data gap analysis and mapping
  • Committed workforce for IDMP compliance
  • Proven record of client success with high quality benchmark
Analytics

While the global implementation is still due for a while, EMA has planned to release its own IDMP Implementation Guide and seeks to implement the same at the earliest. This puts pressure on the European market players to mobilize regulatory efforts quickly to interpret, understand and implement these new guidelines.

News & Updates

4 Effective Strategies to Accelerate Site Selection to Activation

Introduction to the site selection process Clinical research organizations (CRO) predominantly rely on the internal networks and investigator database to support a clinical study for a drug. As the clinical sphere continues to expand at a rapid pace, there is an upsurge in demand for clinical trial sites worldwide. CROs are striving for new sites […]

Aggregate Reporting – Significance, Classification and Challenges

Aggregate reports are the cumulative reports in the database that emphasise on evaluation of safety profile and risk-benefit analysis of a drug. Aggregate reporting is the process of compilation and submission of aggregate reports to the regulatory agencies over the period of the product’s life cycle (during pre-marketing and post-marketing phase) to provide a comprehensive [...]

Literature Screening – Process overview, challenges en-route and the scope for automation

Medical and scientific literature is a valuable source of safety information that helps in monitoring benefit-risk profiles and emerging safety issues of medicinal products. Literature screening is conducted to ascertain abstracts and articles that provide crucial information on serious and non-serious Individual Case Safety Reports (ICSR) reports and risk-benefit assessment of a drug. The scientific […]

Let Us Know How We Can Help You