Regulatory Compliance Systems

Regulation is of paramount importance in the pharmaceutical industry. Drugs and pharmaceutical products have to be approved by competent authority before they are released into the market.

Business Need

• Provide seamless visibility into the entire regulatory document management lifecycle, from document creation all the way to regulatory submissions
• Implement FDA 21 CFR Part 11 compliant regulatory frameworks that is also compliant with other country-specific requirements
  

How Can TAKE Solutions Help?

TAKE offers PharmaReady™ Suite, a web-based electronic Document Management and eSubmission Solution suite specifically designed for both emerging and large Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers. It is designed specifically for management of SOPs, Work Instructions, Training Records, eCTD Submission Documents, and all other electronic documents. PharmaReady is in full compliance with global regulatory requirements.

PharmaReady™ Suite is a tightly integrated, cost-effective document and submission management product tailored to the needs of the following small, medium and large life science companies, including start-up ventures:

• Pharmaceutical
• Biologics
• Medical Device Manufacturers
• Generic Drug Manufacturers
• Animal Health Care
• Clinical Research Organization

PharmaReady™ Suite provides seamless visibility into the entire regulatory document management lifecycle, from document creation all the way to regulatory submissions. PharmaReady Suite is also available à la carte with individual products.

Products/Services

• PharmaReady™ DMS - Document Management System
  
• PharmaReady™ eCTD - Electronic Common Technical Document
• PharmaReady™ SPL - Structured Product Labeling
• PharmaReady™ TRMS - Training Records Management
• PharmaReady™ eTMF - Electronic Trial Master File
• PharmaReady™ PPM – Paper Publishing Module