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© 2019 Alloush LLP

ATTORNEY ADVERTISING: Prior outcomes are no guarantee of future performance

Regulatory & Compliance

State Licensing Practice

 

We represent and advise drug manufacturers, wholesale distributors, virtual manufacturers, third party logistic companies, and pharmacies in ensuring compliance with required professional state licensing. We manage the entire complex process allowing our clients to focus on what matters most - development, commercialization, and distribution of its products.

License Research. State government agencies frequently change requirements and update their forms making it challenging to identify which licenses are required in various jurisdictions.  We assess clients licensing needs associated with every state government agency as well as provide the proper license/permit application forms, filing instructions, list of required supporting documents, and fees. 

 

License Filing. We manage the filing process for clients by obtaining and completing application forms and ensure all required supporting documentation is included. We will do this on an ongoing basis.  

 

License Verification. We conduct research for all clients required licenses in all relevant jurisdictions, obtain confirmation of license status and renewal dates as well as produce a comprehensive report containing state-by-state license information. 

 

We provide licensing services as required by each state for clients which includes:

  • Submitting all required data and documentation.

  • Providing a summary of registration fees.

  • Tracking progress with status updates for each state application.

  • Liaising between clients and state regulatory agencies.

  • Managing the closing process.

  • DSCSA reporting, where required by jurisdiction.

  • Reviewing revisions to state filing requirements.

  • Continuous assessment and monitoring to ensure compliance.

FDA Practice

Our FDA practice includes:

  • US Food and Drug Administration (FDA) Compliance matters.

  • Pathway strategies.

  • Clinical trial design.

  • Investigational new drug, new drug, and biologics license applications.

  • Biosimilar and Hatch-Waxman strategies.

  • Government sales and contracting disputes.

  • Reimbursement strategies.

  • Available market exclusivity assessments.

  • Promotional, reimbursement, marketing, distribution, and pricing strategies.

  • Labeling and advertising matters.

  • Manufacturing processes.

  • Recall, correction, removal, and supply chain issues.

  • Export and import matters.

  • Investigational device submissions.

  • 510(k) and premarket approval applications.

  • Product modifications.

  • Medical device reporting.

  • Medicare and Medicaid coverage and reimbursement.

  • Sunshine, state distribution, and related device-compliance matters.

  • 483 observations and warning letters.