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FDA Compliance Expert, Kristin Grumet, Joins Greenleaf

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Kristen Grumet to Expand Firm's Compliance Capabilities

Greenleaf Health, Inc., a leading Food and Drug Administration
regulatory consulting firm, today announced that Kristen Grumet has
joined the firm as Senior Vice President, Regulatory Compliance.

The addition of Grumet to Greenleaf's team of experts further enhances
the firm's expanded portfolio of comprehensive compliance services,
which now include inspection readiness, on-site compliance assessments,
and remediation.

About Grumet

Kristen Grumet is an expert in the field of medical device compliance.
In addition to almost a decade of experience as an FDA field
investigator, Grumet's professional background includes 16-years of
quality systems compliance management and consulting within the medical
device industry.

A Phase II-certified medical device performance auditor, Kristen has the
distinction of being among the first cadre of certified medical device
investigators in FDA history. During her service at the FDA, Grumet
inspected both domestic and International medical device manufacturers
to ensure compliance with Quality System Regulations (QSRs). Grumet was
responsible for documenting and developing numerous regulatory cases,
including warning letters, seizures and corporate-wide injunctions.

Grumet's 20+ years of industry experience includes positions at NSF
Health Sciences; Intuitive Surgical, Inc.; Quintiles Consulting; and
LifeScan, Inc. Her work with medical device companies provided
experience leading projects across the spectrum of quality assurance and
regulatory compliance activities, including compliance assessments;
internal audits and investigations; quality systems development and
implementation; corrective action planning and quality system
remediation; and QSR and FDA inspection readiness training. Grumet's
impressive portfolio also includes numerous FDA and industry
presentations and publications.

At Greenleaf, Grumet joins the firm's Product Quality, Manufacturing &
Compliance team, where she will serve as Senior Vice President,
Regulatory Compliance. In this role, Grumet will continue to provide
medical technology clients with customized guidance and support in
developing and implementing strong corporate quality systems and
regulatory strategies for compliance.

Greenleaf's Expanded Compliance Services

Greenleaf's Product Quality, Manufacturing, and Compliance Team has a
proven track record of providing excellent services to life science
companies seeking strategic and technical expertise to strengthen their
quality management systems and guide them through challenging quality
and compliance matters. In addition to Greenleaf's core regulatory
consulting services, the firm recently expanded its compliance service
portfolio to include expanded remediation, auditing, and compliance
services. Greenleaf's compliance capabilities now include:

  • Inspection Readiness: Greenleaf experts strengthen clients'
    readiness for FDA pre-approval and surveillance inspections through
    training, mentoring, audits and mock inspections.
  • Compliance Assessments: Greenleaf works with life science firms
    to evaluate and strengthen compliance functions with an eye towards
    optimizing processes, mitigating risks, and creating a culture of
    compliance. The Greenleaf team performs objective audits and
    assessments of a clients' operations to identify strengths and areas
    of needed improvement, while continuing to meet business objectives.
  • Compliance Remediation: Greenleaf's experts bring an unmatched
    level of experience and insight when guiding companies along the
    remediation pathway. Greenleaf's services address the complete scope
    of remediation, from acute enforcement actions, to strategic
    development and implementation of remediation plans.

By expanding Greenleaf's compliance service portfolio, the firm is now
capable of providing a full-service experience for companies navigating
today's evolving FDA regulatory environment.

About Greenleaf Health

Greenleaf Health provides strategic and technical guidance to
pharmaceutical, biotechnology, and medical device companies developing
and manufacturing innovative solutions to pressing global public health
challenges.

Greenleaf's team of experts draws on a combined total of more than 200
years of FDA experience. Members of the firm's Product Quality,
Manufacturing, and Compliance Team include former leaders and regulatory
experts from the FDA, Capitol Hill, top global pharmaceutical companies,
leading law firms and the top U.S. biotechnology trade organization.
Greenleaf's robust blend of regulatory expertise and FDA institutional
knowledge allows the firm to provide unmatched regulatory guidance.

For more information on Kristen Grumet and Greenleaf's comprehensive
compliance services, visit greenleafhealth.com.

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