Strategic Advisory Services

MCRA is the world leading regulatory advisor to the neuro-musculoskeletal industry on U.S. FDA related activities. Whether assisting on specific subjects or executing on complex pipeline strategies, MCRA’s regulatory team is a value-add to any potential client. MCRA’s distinguishing characteristics in providing these world-class strategic advisory services is due to:

  • 1
    Domain specific regulatory expertise in orthopedics (general orthopedics, sports medicine, spine, biologics, trauma, new developing niches);

  • 2
    Mechanical engineering and biological backgrounds able to assist with pre-clinical and clinical strategies, and is able to effectively communicate these strategies to internal and regulatory constituents;

  • 3
    Long-term working relationships with the FDA and an instinctive understanding of FDA reporting processes and timelines; and d)

  • 4
    Senior level involvement.

    As a small boutique firm, MCRA works closely with clients in developing ideas and providing sound judgment. MCRA’s integrative multi-disciplinary approach in offering clinical, regulatory and reimbursement services allows MCRA to consider important factors that impact the cost, timing, and success of getting a product effectively approved and paid for.

With decades of experience with both industry and FDA, MCRA understands how to navigate the regulatory approval process and provide the highest-quality regulatory strategic advisory services. These include:

  • 1

    Predicate
    Landscape &
    Device Design

  • 2

    Balancing
    Indications,
    Costs &
    Claims

  • 3

    Leveraging
    Regulations,
    Competition,
    & New
    Opportunities

  • 4

    Reviewing FDA
    and other
    pertinent
    regulatory
    guidelines

  • 5

    Incorporating
    the regulatory
    and clinical
    testing
    requirements
    into the
    product
    development
    process

  • 6

    Developing
    clinical study
    protocols in
    support of
    regulatory
    submissions,
    marketing and
    reimbursement
    activities

  • 7

    Providing
    technical,
    clinical and
    management
    oversight
    during clinical
    studies

  • 8

    Conducting
    meetings with
    the FDA and
    other
    regulatory
    agencies

  • 9

    Evaluating the
    regulatory
    impact on
    marketing
    campaigns

 

To speak to a strategic regulatory advisor, please call 202.552.5800

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise

GLENN STIEGMAN

Vice President Clinical and Regulatory Affairs

Mr. Stiegman manages and directs the clinical and regulatory affairs departments for MCRA and its clients. Mr. Stiegman is responsible for management of approximately 15 clinical and regulatory professionals at MCRA. Mr. Stiegman leads the firm's submission process, regulatory strategy, analysis and development: from pre-clinical testing, to FDA submissions Read More

PH: 202.552.5803

EMAIL