Pharmaceuticals

eDelta’s Pharma Practice provides comprehensive risk management assistance to the pharmaceutical and biotechnology industry. Companies in the Pharma sector are under continual pressure to meet customer demands for new products and services and simultaneously comply with the growing burden of regulation. The challenge this creates in building and maintaining the supporting operations and infrastructure is tremendous and the resulting risks to the business are significant.

To address the needs of our Pharma clients, we focus on providing quality financial, operational and technology audit and compliance services. Some of the key services eDelta provides include:

  • Compliance Program Development, Management and Execution
  • IT Security Assessment and Strategy Development
  • Internal Audit Outsourcing and/or Assistance
  • Financial, Operational and Technology Policies and Procedures Development
  • Business Process Evaluation/Re-engineering
  • Business Continuity Planning and Disaster Recovery
  • Data Analysis

Increased scrutiny and accountability requirements come from a variety of sources and Pharma companies must comply with a myriad of statutes, rules and regulations promulgated and administered by the FDA and other entities. As such, it is now more important than ever to develop reliable and repeatable processes for managing compliance requirements and an overall framework for controlling corporate risk.

eDelta consultants have expertise in several specialized areas, including:

  • FDA Rules and Regulations
  • HIPAA
  • Sarbanes-Oxley
  • CFR 21 Part 11
  • LIMS
  • Adverse Events
  • Patient Safety
  • Charge Back Processing
  • Statistical Analysis Tools
  • Quality Document Controls