Introducing Compose
Streamline your FDA submissions while meeting the requirements brought about by the FDA's effort to standardize PQ/CMC data. Make your data submission efficient with a user-friendly interface and tools that simplify the process of organizing the data to be submitted. Ensure your data submissions comply with the standardized format required by the FDA in Module 3 of the eCTD, reducing the risk of errors and delays.
Discover
PQ/CMC Project
The PQ/CMC Project is an effort by the FDA to identify and standardize data elements and terminologies used in drug applications in Module 3 of ICH eCTD to improve the quality and consistency of information submitted to the FDA. Compose is being implement in parallel to the rollout of the PQ/CMC IG. Early access not only prepares for this transition to structered data exchange, it is a door to influence development, including features to facilitate integration with your existing software systems. Output in different formats will ensure entered data will be applicable worldwide.
What is FHIR®?
HL7 FHIR® enables the seamless and secure exchange of health care information, enabling patients to receive the best possible care. With its extensive set of rules and specifications, its interoperability and modern information exchange in the health care industry. Since the initial presentation in 2012, it continues to expand and support the further reaches of health care including drug development. It provides an API based on established web standards and modern information exchange.
Simplify
Compose simplifies the task of creating FHIR XML files because it is unnecessary for pharmaceutical developers and regulatory professionals to know the mechanics of how a document is encoded. Module 3 is filled with diagrams, molecular images and more that are delt with in FHIR® as attachments in compressed form. Compose imports molecular formulas and chemical structures including SDF and does the compression and packaging into XML.
A Data Sherpa
As you enter data, validation of required field cardinality and data types is provided in tooltips and messages. Business rules are built in. Terminologies are associated with the fields according the FHIR® PQ/CMC IG requirements. Those requirements can easily be forgotten during data entry. Rely on a guide on a new terrain.
Integrated Access
Connect via APIs to GSRS and Kew Gardens databases. Effortlessly access GSRS UNII codes for substance nomenclature and load any identifiers, formulas and chemical structures with point and click ease. Access the Kew Gardens’ comprehensive datasets on plant and fungal taxonomy, including accepted names, and synonyms created in collaboration with scientists from around the globe directly from the application.
Commitment
We are dedicated delivering innovative technologies that secure drug quality. Our commitment extends to other organizations with whom we work.
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Preview Compose
Watch a better process of creating FHIR® XML files for regulatory submissions.
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