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> > > REAT |
 Regulatory
Event & Activity Tracking (REAT)
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Pharmaceutical companies of all sizes face the daunting challenge of managing drug
product submission, compliance, and tracking. These extensive multiple demands require
automated solutions that supply users with real-time data that meet strict regulatory
requirements. DoubleBridge Technologies, Inc. can help companies meet these challenges
with a sophisticated Regulatory Event & Activity Tracking (REAT) system developed
after years of extensive field experience.
Features:
Allows a complete overview of products that have been submitted, approved, and launched
at the local, regional, and global levels.
Maintains key domestic and international product data including description, active
ingredients, strength, dosage form, route of administration, product lines, and
international birth date.
Provides project management tools for business units that support registrations
and renewals.
Identifies areas of non-compliance during the submission process permitting trend
and metrics analyses.
Coordinates drug submission communications through system-generated email.
Establishes tight security control using role, group, market and product based access
rules.
Complies with current regulatory guidelines including National, Central and Mutual
Recognition Procedures.
Allows easy configuration and deployment to manage internal information and global
registration activities.
Is a 21 CFR Part 11 compliant and validated system.
Includes pre-built and ad-hoc reports.
Tracks regulatory requirements for all stages of the drug development process.
Monitors regulatory requirements for various submission types including IND, NDA,
and Device.
Tracks regulatory procedure, sample, certificate and dossier requirements.
(Click to view the REAT online demonstration video!)
Benefits:
Shortens the approval cycle by ensuring accurate data and streamlined management
of all registration data and submission activities.
Reduces the time, costs, and risks associated with the registration process by improving
management and tracking of submission activities.
Streamlines the regulatory affairs workflow and improves time to market by eliminating
inefficient manual tracking.
Guarantees real-time access to registration and submission and related tasks.
Improves the accuracy of registration data for all products, indications, and formulations.
Back to iPharmaTrack
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