The Biotech segment of the industry offers special challenges.  Not only are corporate governance, financial, and risk management tasks daunting, but performing these tasks in the face of the regulatory, legislative and best practice demands takes it to a new level.

elanlab copy

Compliance with FDA regulations, other government requirements, and industry practices generally require transparency in the methods by which information is managed and disseminated throughout the business operation.  Many startup operations employ manual information tracking, which can create a very inefficient system.  When the NDA needs to be filed, a manual system could extend that task by months over an automated system.  This is not the time in the drug development process to experience delays.

The Challenges

For Senior Management, the risk of noncompliance is lost business and lost opportunity.  Questionable compliance at best delays promising therapies coupled with the potential for expensive audits and corrective action.

For Functional Managers, the time required to achieve compliance is time not spent moving the core business forward.  In working with peers in the organization, the management of information across functional boundaries and ensuring that inconsistent duplicate information doesn’t exist is a consuming effort.

For Users, the challenge of understanding the complexity of compliance can serve as a distraction from accomplishing excellent science.

For IT Managers, ensuring that solutions are not only deployable but also scalable and robust.

The Pivotal Point Group understands these challenges - we’ve been there - and stand ready to take the burden of compliance strategy development so that advancement of the core business can take place.

Our services include:

  • Development of a Regulatory Dossier
  • Representation to Regulatory Authorities
  • Equipment and Process Validation and Qualification
  • Preparation of Response(s) to Regulatory Agencies
  • Development of Electronic Documentation Systems for 21 CFR Part 11 Compliance - see GAMP 5 compliance strategy

For a more complete list of the offerings of The Pivotal Point Group, see the Drug Pipeline

Copyright 2013 The Pivotal Point Group, LLC