Regulatory Management

Regulatory Management

Regulatory Management

Our multidisciplinary consultants will help you to shorten approvals time in the MENA region, in addition you can outsource to our internal and external experts, as they possess extensive experience in MENA countries regulatory requirements.

Our Regulatory Management Services include:

  • Regulatory Services to Fulfill Submission Requirements.
  • Specialized Expertise to Help Speed Approvals.
  • Targeted Partnering for a multiple countries submissions in One-Go Regulatory Activity.
  • Regulatory Meeting Advice.
  • Maintaining and Expanding Products in Specific Countries or Regions.
  • Regulatory and Clinical Trial Applications & manage.
  • Product Acquisition, Integration and Licensing Services.
  • Product Portfolio Analysis.
  • Product development
  • Specialized Expertise to Help Biosimilars to Fulfill Submission Requirements in MENA.
  • Dossier preparation, production, submission, and maintenance.
  • eCTD Preparation and maintenance.
  • CTD conversion to eCTD.

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