Compliance & Regulatory Quality Systems Optimization

Source: Halloran Consulting Group


An effective quality system is critical to compliant research and thus regulatory approvals.

Quality systems consulting is a core offering for Halloran.  We have helped clients from single product start-ups to some of the world's largest pharmaceutical and medical device companies create and optimize their quality systems. Our quality experience includes development of quality manuals and policies, standard operating procedures (SOPs), work instructions, quality assurance (QA) processes, training, and regulatory inspection readiness programs.

In addition to helping companies construct quality systems, Halloran has led comprehensive quality systems assessments at dozens of companies, identifying process and compliance gaps and recommending immediate and long term solutions that align with industry best practices.  We work with clients to ensure their new systems are customized for the company's development stage, product portfolio, and business reality.

Mergers, acquisitions and joint development programs require that quality systems harmonization projects succeed. The companies involved with these partnerships frequently have little bandwidth on the internal team to harmonize and train staff on new procedures. We have led numerous global quality integrations, bringing together the best practices from each partner into a single, compliant system.

System Optimization Services

  • Quality and compliance gap analysis
  • Quality system development
  • Quality system optimization
  • Quality system harmonization
  • Gap remediation
  • Quality system training