Strengthen compliance and efficiency for regulatory electronic submissions

For life sciences, medical device manufactures, and pharmaceutical firms, innovation is pivotal to growth and competitive differentiation. But gaining an edge can’t come at the cost of compliance. These organizations require the capacity to securely and efficiently submit regulatory data to compliance organizations across enterprise and geographic boundaries. Deploying an advanced eSubmissions Gateway facilitates efficient and cost-effective collaboration with all industry regulators.

How the Cleo Integration Cloud benefits community management

Cleo Integration Cloud provides a powerful and innovative eSubmissions Gateway solution to secure the conduit between global pharmaceuticals, medical device, and life sciences enterprises and multinational regulatory bodies.

CIC helps your enterprise streamline electronic submissions dataflows and bidirectional collaboration with the FDA and EMA. Optimally realize compliance across product lifecycle processes in the biotech and medical manufacturing industries.

Automation

Eliminate inefficient, unsecure manual process such as fax, email, and postal delivery for up-to-date regulatory approval, extension, transfer, variation, and revocation document submissions

Compliance

Support submission criteria and comply with international, federal, and industry regulatory organizations including HHS, FDA, CDER, CBER, NCA, and EMA

Industry-mandated protocols

Facilitate regulatory eSubmissions across complex digital ecosystems with extensive industry-mandated protocol and format handling

Format agnostic

Send and receive data in any format including the Article 57 format (XEVPRM) and HL7 standards

Certification and compliance

Maintain e-signature integrity and validation for compliance with CFR Title 21 Sec. 11

Data transformation

Support data transformation for XML schema definitions required for EU and APAC eSubmissions

Tracking

End-to-end tracking and traceability for document submissions with delivery notifications and receipts for provable non-repudiation

Transfers

Enable secure eSubmissions with transmission authentication and encryption

Audit logging

Provide searchable logging and audit trails to easily meet compliance auditing requirements

Control

Employ targeted document routing to ensure the destination-specific delivery of regulatory data

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B2B gateway

Rapidly connect to government agencies for secure collaboration and compliant eSubmission

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Cloud integration

Cloud-based storage and process integration optimizing medical data movement and management flows

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File acceleration

Add velocity to the transfer extremely large files employing unrivaled proprietary protocol technology

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Data transformation

Comprehensive format transformation to streamline the integration of diversified data

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Careers

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