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An IS0 9001:2015 Certified Institute

Total Services by Sadhana Infotech

  • Regulatory affairs strategy for your product portfolio
  • CMC & Quality Assurance Compliance
  • Preparation of CTD modules 2 and 3
  • Preparation of clinical and non-clical sections (Module 2.4, 2.5 & 2.7,PSUR,RMP,)
  • New filing services for US and EU (MRP,DCP & National) and ROW makets
  • advice on the updated guidelines, rules and regulations
  • Variations/post approval changes to marketing authorizations
  • Renewal of marketing authorizations in the EU
  • Gap analysis and remediation
  • DMF preparation
  • CTD/NeeS/e-CTD submissions

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Our Services