Solution developed to help biopharmaceutical companies meet emerging regulatory requirements ahead of deadline
PAREXEL International, a leading global biopharmaceutical services provider, has launched an Identification of Medicinal Products (IDMP)-focused solution for biopharmaceutical companies.
LIQUENT InSight for IDMP is the newest module added to PAREXEL’s Regulatory Information Management (RIM) platform.
Beginning in 2018, the European Medicines Agency (EMA) will require biopharmaceutical companies to submit data on medicines in accordance with the International Organisation for Standardisation (ISO) IDMP standards. Other major global market regulatory agencies are expected to follow suit. The standards are designed to increase transparency into authorised and investigational medicinal products to improve patient safety.
PAREXEL’s LIQUENT InSight for IDMP allows biopharmaceutical companies to collect their data in a comprehensive and holistic manner.
It is fully compliant with the five ISO IDMP standards defining product and registration data and details for investigational and registered medicinal products. In addition, PAREXEL Consulting’s subject matter experts work with clients to develop a comprehensive IDMP strategy that ensures globally standardised data.
“As biopharmaceutical companies establish their IDMP programmes, they will require capabilities to help them meet global standards and eliminate complexity,” said Paul Bidez, PhD, Vice President, Regulatory Solutions, PAREXEL.
“Our solution combines deep subject matter expertise, specialised master data management, integration services, and purpose-built technology. With this new offering, PAREXEL clients gain a well-structured IDMP programme with the potential to ensure compliance, provide greater efficiency, reduce costs and simplify processes.”
PAREXEL’s end-to-end IDMP solution is available around the world, directly from PAREXEL or through the PAREXEL Partner Program. The solution can be deployed on-premises or in PAREXEL’s Regulatory Cloud, a life sciences content and regulatory information management solution structured within a dedicated, private cloud environment. For more details click here.