Expert Life Sciences Consultants Chicago San Diego San Francisco IndianapolisOur experienced project managers are known in the Life Sciences industry for successfully navigating the demands and complexities of a changing regulatory marketplace.

With an improved Project Management Processes, your organization / functional area can operate at maximum potential.

What do your teams need help with?

Tell Us About Your Project

  • Program & Project Management Experts

    When life sciences organizations fail to prioritize projects and make key decisions, projects will fail. This outcome is avoidable with the help of our expert project management consultants. We have the expertise to set your PMO up for success.

    Learn More
  • Pharmacovigilance / Drug Safety

    Avoid project failure with a pharma project plan. Put in place a plan for risk management, signal detection and signal management with the help of consultants who understand the pharmaceutical life cycle. Successful Pharma organizations are forward-thinking - they improve their process now, not after a failed project. Our clients view Pharmacovigilance as a strategic function of their company.

    Learn More
  • Quality Assurance / Quality Systems

    A quality system is the very core of how a pharmaceutical/biotech company can maintain or enhance quality in every facet of their processes, stay aligned to the expectations of key internal/external stakeholders (e.g., regulatory agencies, patients), and support the company’s commitment to delivering world-class medical treatments.

    Learn More
  • Software Quality Assurance & Validation

    Our computer system validation and software quality consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations. We have developed
    educational courses and webinars that help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your projects to maximize the impact of your compliance and quality efforts.

    Learn More
  • Mergers & Separations

    Large Pharmaceutical company mergers put projects in peril, teams under stress, and can result in lack of innovation and loss of value. Our project managers understand these challenges and provide the experienced leadership these teams need to successfully complete projects during a big merger or a separation.

    Learn More
  • Clinical Development

    The success of a clinical development project is important on many levels - ultimately to the patients who will receive the drug, but also to organizations that rely on reliable results and successful approval from the FDA and other licensing boards.

    Learn More
  • Global Medical Affairs

    The role of the Global Medical Affairs (GMA) function is to educate stakeholders about their medical treatments through the development and delivery of accurate, complete, and unbiased information. Another primary objective is the execution of interventional/non-interventional Phase IIIb/IV trials. GMA activities must comply with local/regional, industry, and company regulatory policies and are not designed to "promote" a product or substitute for Sales and Marketing practices.

    Learn More
  • Health Economics and Outcomes Research (HEOR)

    HEOR is a scientific discipline that quantifies the economic and clinical outcomes of medical treatments. With our experience working with HEOR organizations, we apply and customize our proven project management, process improvement, and change management methodologies to our clients’ business needs.

    Learn More