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Regulatory Activities - Europe

Pharmaceuticals

✿ Pre IND / Pre IDE / Pre Submission Meetings
✿ Non Clinical Studies Planning and Report
✿ eCTD Application Ppn (All modules & CMC )
✿ Type of variations, classification, Requirement and Submission
✿ SPC, PIL, Mock UP, Labeling etc.,
✿ Post Marketing Surveillance
✿ Pharmacovigilance
✿ Periodic Safety Update Reports
✿ Renewals
✿ Import/Export

MD / IVD

✿ Notified Body Selection, Interaction
✿ Product Classification
✿ section of CAP
✿ Technical File Structure
✿ Technical File Compilation
✿ Design Dossier Review, DHF
✿ Writing various specific SOPs
✿ Post Marketing FollowUp
✿ Import/Export







Technical File Support

✿ Technical Documentation Structure, Content & Review
✿Device Description, Principle,
✿Classification & Choice of NB
✿Intended Use/Purpose
✿Declaration of Conformity (DoC)
✿General Safety and Performance Requirements Checklist (GSPR)
✿Label, Instructions for Use
✿Software Development, Verification & Validation
✿Risk Management Plan, Process, Report & Review
✿Cybersecurity
✿Traceability Matrix
✿Biocompatibility
✿ Usability Engineering
✿ Clinical Evaluation Plan, Process, Report & Review
✿ Manufacturing and QMS Documentation
✿ DMR
✿ Post Marketing Survellance Plan, Process, Review & Report
✿ PSUR, FSCA
✿ Compliance to all the standards
✿Compliance to Other Directives





Regulatory Activities - USA

Pharmaceuticals

✿ Scientific Advice on 21 CFR
✿ FDA Pre Submission Meetings
✿ Non Clinical Studies Planning and Report
✿ eCTD Document Preparation
✿ Type of variations, classification, Requirement and Submission (CMC)
✿ Postapproval Studies
✿ Postmarket Surveillance
✿ Pharmacovigilance
✿ Periodic Safety Update Reports
✿ Renewals
✿ Import/Export

MD / IVD

✿ Device Classification
✿ Scientific Advice
✿ FDA Pre submission meeting package preparation
✿ Class II or Class III eCopy Application
✿ 510K Application
✿ Pre Market Approval
✿ Post marketing clinical follow up
✿ Device Tracking
✿ Import/Export





Regulatory Activities - ROW

✿ Rest Of the World (ROW) Registrations
✿ Legalization across the world
✿ Notarization across the world
✿ Communication and Meetings with the Authorities
✿ Free Sales Certificate Import Licence
✿ No Objection Certificate Type Certificate
✿ Other Registration requirements across the world





Registration in the ROW Regions

✿ Indian Subcontinent
✿ Japan
✿ APAC (Asean & Pacific Market)
✿ Greater China
✿ Africa
✿ Benelux
✿ CEE
✿ DACH
✿ EEA & Non-EEA
✿ FRANCE
✿ IBERIA
✿ IIG
✿ Middle East & Turkey
✿ Nordics
✿ Russia & Central Asia
✿ UK & Ireland
✿ LATAM
✿ North America