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    • Home
    • About
    • Auditing
    • Remediation
    • Regulatory
    • Inspections
    • Consulting
    • Training
    • Blog
  • Home
  • About
  • Auditing
  • Remediation
  • Regulatory
  • Inspections
  • Consulting
  • Training
  • Blog

Regulatory Support

TCG has former agency regulatory reviewers and industry regulatory affairs experts who have reviewed and submitted regulatory submissions. We assist companies with developing regulatory strategies for submissions and help them prepare dossiers and meeting packages for agency meetings. 

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Services

TCG has aided clients by providing strategic consulting to address complex regulatory situations. We also have the expertise and experience to prepare, review, publish, submit, and/or advise on regulatory submissions, and work with senior leadership to formulate a strategy that evaluates potential options and the likely outcomes to provide a robust action plan. Our team is ready to attend Regulatory Agency meetings with clients to provide guidance and expertise, as well as plans for oversight, verification activities, and/or remediation support as needed.

Regulatory Strategies and Submissions Include

  • Submission Pathways and Strategy
  • Clinical Development
  • FDA / Agency meeting preparation
  • Representation during FDA/Agency meetings
  • Medical Device: IDE, 510(k), PMA, Letters to File, etc.

  • Drugs and Biologics: IND, ANDA, 505(b)(2), NDA, BLA, Biosimilars
  • Active Ingredients: DMF 
  • Annual Reports 
  • Interactions with EMA Innovation Task Force (ITF)  
  • Supplements: CBE 0, CBE 30, PAS

Additional services are also provided; please inquire below.

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Have Questions?

Thank you for your interest in Toscano Consulting Group (TCG). Do not hesitate contacting us for any of your consulting needs.

Toscano Consulting Group

Phone: (786) 201-3663 Email: operations@thetcg.org

Hours

Mon

09:00 am – 05:00 pm

Tue

09:00 am – 05:00 pm

Wed

09:00 am – 05:00 pm

Thu

09:00 am – 05:00 pm

Fri

09:00 am – 05:00 pm

Sat

Closed

Sun

Closed

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