The Problem
Market forecasters predict that the plant-made pharmaceutical (PMP) market will be valued at $20 billion by the end of the decade. This promising industry offers effective treatments for many serious diseases such as cancer, HIV, hepatitis, and heart disease. Potentially, the industry could reduce the cost of drugs and increase the availability of medicines for people everywhere.

Yet, the growing and harvesting of PMPs poses numerous challenges to biotechnology companies. To begin with, each step in PMP manufacturing is rigorously monitored through a permit process by the USDA and the FDA. Secondly, failure to adhere to permit requirements could result in full-scale government investigations and severe civil penalties.

To work successfully within the regulatory permit process, it is critically important for companies to understand the agencies and their respective responsibilities; it is also indispensable for companies to enlist skilled guidance throughout the entire permit and production cycle.

The Solution
Having more than a decade of domestic and international experience in helping companies satisfy government and consumer regulatory requirements, Critereon is expertly equipped to cost-effectively help pharmaceutical / biotechnology companies achieve compliance with USDA and FDA permit and production policies.

CRITEREON WORKS WITH YOU TO MANAGE THE DETAILS

Critereon helps companies develop the following tools to help you comply with and develop permit applications for USDA and FDA regulatory Agencies:

• Design and review permit plans for Plant-Made Pharmaceuticals during development and field production
• Create documentation for achieving compliance with field confinement, pollination timing and dedicated equipment
• Develop systems to assure proper harvest, storage and interstate shipment of PMP products
• Produce record systems for the inspection of fields, laboratories, greenhouses, storage facilities and equipment—both before, during and after harvest

Critereon’s consultative approach to helping you meet your compliance needs means that we go beyond selling technology and systems. We have the appropriate connections to put you in direct communication with the regulatory agencies so that you can achieve a thorough understanding of how to comply with government requirements. And, we concentrate on the slightest detail and roll up our sleeves to create a trouble-free management structure for your PMP business.

IN ADDITION TO OUR CUSTOMIZED SOLUTIONS APPROACH, YOU WILL GAIN THE BENEFITS OF CRITEREON’S UNPARALLELED TECHNOLOGY:

• Authentix™ for Biotech Compliance Authenticity provides a comprehensive checks and balances system for your PMP products
• Critereon’s experts have configured Authentix™ to address international trade requirements for exporting PMP / biotech products
• Authentix™ for Biotech Compliance Authenticity is multilingual and completely functional in major world languages
• Authentix™ for Biotech Compliance Authenticity interfaces with your trading partners’ data systems for a reliable exchange of vital data and communications.

Critereon Authentix™ for Plant-Made Pharmaceutical / Biotech Compliance

Managing for Success