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Legislative and Regulatory Affairs

imageWe provide pharmaceutical consulting services to clients in connection with Maine, Massachusetts, Connecticut, New Hampshire, New York, Rhode Island, Pennsylvania and Vermont regulatory and governmental affairs issues. We can and have provided content lobbying on many national pharmacy issues to various clients and lobbyists. We have written a number of white papers explaining very complicated issues related to pharmacy reimbursement and formulary management. We stay current on regional and national legislative and regulatory issues and stand ready to work with any client to understand and manage issues important to their business.

Typically IPS performs pharmaceutical consulting activities for clients that include:

  • Providing guidance on and monitor regulatory and governmental affairs issues presented before key regulatory agencies.
  • Establishing and maintaining key allies, including, but not limited to, agencies within the Department of Health and Human Services as well as organizations in the Department of Public Health.
  • Monitoring and providing regular updates regarding ongoing developments with the State Medicaid Drug Lists, state purchasing and formulary developments.
  • Attending and providing regular updates from State DUR Board Meetings.
  • Assisting with various regulatory and legislative research projects as requested.
  • Guidance with State and Federal regulations
  • Represent and support clients facing key regulatory agencies for:
    • Licensing
    • Complaint Resolution and Corrective Action Plan development, implementation and on-going monitoring
    • Regulatory Compliance Audits
    • Provide industry guidance to lobbyists

SAMPLE PROJECTS

  • A number of national pharmaceutical companies retained IPS to monitor legislative and administrative issues of interest to that company. IPS prepared written summaries of those issues, provided advice as requested, assisted in the review of testimony, tracked the progress of various initiatives, collected information from government agencies and interest groups, coordinated communications and interactions with state officials and interest groups and appeared before legislative and administrative bodies on behalf of that company.
  • A law firm retained IPS on behalf of their client who was seeking regulatory relief from a Board of Registration in Pharmacy (BRP) to allow the client to continue using their current dispensing procedure. IPS reviewed the procedure and provided an assessment report regarding compliance with applicable state laws and regulations. In addition, IPS drafted a waiver for the BRP, attended the meetings with the client, and assisted in the efforts geared toward a legislative solution to the issue.
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