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.