Regulatory Affairs Processes - EU

Regulatory Affairs Processes - USA

Regulatory Affairs Processes - Global

Types Of Procedure(EU,USA)

EMA Pharmaceuticals

✿Centralized Procedure (CP)
✿Mutual Recognition Procedure (MRP)
✿Decentralized Procedure (DCP)
✿National Procedure (NP)
✿Generic Appln


✿Various Conformity Assessment Pathways (CAPs) for various Risk Classes based on MDR/IVDR


✿Premarket Notification 510(k)
✿ 510 (k) Excemption
✿ IDE and PMA

FDA Pharmaceuticals

✿505 (b)(1) NDA/NADA
✿ 505 (b)(2) NDA

Special Situations


✿ Early Access
✿ Accelerated
✿ Conditional Marketing
✿ Compassionate Use Program (CUP) / Expanded Access / Managed Access Program
✿ Named Patient Programme


✿ Off-Label Use
✿ Expanded Access / Speed Access / Compassionate Use
✿ Single Patient IND / Emergency IND
✿ Emergency Use

AUS / Canada

✿ Special Access Scheme (SAS)

Regulatory Activities - Europe


✿ 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


✿ 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

✿Traceability Matrix
✿ Usability Engineering
✿ Clinical Evaluation Plan, Process, Report & Review
✿ Manufacturing and QMS Documentation
✿ Post Marketing Survellance Plan, Process, Review & Report
✿ Compliance to all the standards
✿Compliance to Other Directives

Regulatory Activities - USA


✿ 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


✿ 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
✿ EEA & Non-EEA

✿ Middle East & Turkey
✿ Nordics
✿ Russia & Central Asia
✿ UK & Ireland
✿ North America

Free Sales Certificate (FSC)

✿ The Certificate of Free Sale, also known as Free Sales Certificate, Certificate of Marketability, FSC or CFS can be ordered by you or by your EU Authorized Representative at the local competent authority upon request. A legalized Free Sales Certificate acts as a proof of compliance with one of the most demanding regulatory systems in the world.
✿ It is also often a fast and cost-efficient way to sell your products in markets outside the European Union. We can help you to enter different markets worldwide – with Free Sales Certificates for your medical device or In vitro diagnostic products! Many countries outside of the European Union without an own regulatory system accept the CE Mark for the import and sales of medical devices on their markets.


✿ Several countries are member of Apostelle Convention
✿ Several countries require only Notarization
✿ Many countries require Legalisation
✿ The procedures for Legalisation is different for each country.
✿ We can help you to organize the necessary documents and order the Free Sales Certificate as well as taking care of the Legalisation