Quintiles Consulting - - BioPharm International


Quintiles Consulting

BioPharm International
Volume 18, Issue 12

Company Description

Quintiles Consulting provides global regulatory, compliance, and validation consulting services to the pharmaceutical, biologics, and medical device industries. In addition, the company provides product development services to the medical device industry. Quintiles Consulting has helped many pharmaceutical, medical device, and biologics companies successfully meet regulatory requirements as well as their own business objectives.

Why Quintiles Consulting?

  • Quintiles Consulting offers a unique combination of government and industry experts to ensure that what needs to get done gets done.
  • Our experts consist of former FDA investigators (Team Biologics; certified medical device investigators, and expert pharmaceutical, biologics, and bioresearch investigators), former Center compliance staff, and former senior managers that together can provide a unique FDA perspective of clients' state of compliance and identify true regulatory risks.
  • Former industry professionals with extensive "hands-on" experience in the practical aspects of implementing policies and procedures that meet regulatory requirements that are also compatible with and supportive of clients' business interests and needs.
  • Former notified-body auditors and EU officials who understand European directives, local member-state implementation, and the various industry and societal cultures.

Tangible Results

  • Quintiles Consulting has done it! Quintiles Consulting has a proven track record of helping companies avoid and overcome compliance problems, implement successful compliance programs, and successfully introduce new products to the global economy.
  • A core team approach has proven valuable in creating sustainable quality systems that serve companies' regulatory and business needs.
  • Sophisticated project management techniques provide the discipline to ensure all efforts remain focused on the clients' objectives.
  • Oversight and involvement by senior management ensure a successful outcome.
  • Integrated solutions provide comprehensive assistance in meeting clients' objectives.

Quintiles Consulting Services Compliance and Quality Systems

  • Gap analysis
  • Compliance program development, implementation, and training
  • FDA inspection readiness training and assistance
  • GMP/QSR training
  • GMP/QSR corporate policies and standard operating procedures
  • Sustainable quality systems
  • Corrective action management training and implementation
  • Independent third-party QSR, GMP, GCP, GLP, and ISO-9000 auditing
  • Mock FDA inspections
  • Supplier due diligence auditing


  • Validation strategy and program development
  • Validation assessments
  • Validation master planning
  • Process validation
  • Equipment qualification
  • Facility and utility validation
  • Software/21 CFR Part 11/computer validation
  • Analytical method validation
  • Cleaning validation

Global Device Development

  • Product development strategy
  • Regulatory submissions: United States and worldwide (EU, Japan, and Australia)
  • FDA and notified-body liaison
  • Clinical research support
  • Device validation
  • Authorized representation
  • Reimbursement strategies


  • Customized training programs to meet clients' requirements
  • Train the trainer programs
  • Training available in
  • Executive management responsibility
  • FDA inspection readiness
  • Validation
  • Electronic records and submissions (21 CFR Part 11)
  • How to avoid a warning letter
  • Conduct of clinical trials
  • Other programs available

1601 Rockville Pike, Suite 300 Rockville, MD 20852





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