Dossier Creation Submission
Electronic / Paper technical data preparation with local forms/application and actual submission to respective Health Authority.
Labeling Management
Preparation of draft Labels for Primary and Secondary Packaging Materials, Patient Information Leaflet & SmPC. Side by Side comparison of Labels in reference to innovator.
Local Translation
We support translation of dossier as well as labeling content in multiple languages.
Agency Meeting
Arranging meeting schedule with Health Authority for technical discussion.
Query Response
Preparation of query response based on Health Authority’s query and timely submission
to our client / authority.
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Documentation of dossiers as per national and international requirements and in agreement with all legal technicalities |
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Dossier compilation in CTD (modules 1 – 5 or any requisite module) and eCTD formats for national as well as international markets like EU, USA, UK, |
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Dossiers preparation for ASEAN and ROW countries in ACTD/ as per country specific format, for any dosage form. |
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Dossier reformatting to CTD / eCTD by taking up gap analysis of existing dossiers in line with current requirements. |
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Product information update (SmPC, PIL and Labeling). |
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Preparation of Drug Master File and Certificate of suitability
(open and closed part) |
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| > | Formulary dossiers |
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| > | Health claim dossiers |
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CTD Dossier
FORMAT : CTD GUIDELINE (EU / ICH / ROW)
Module 1 - Administrative Information and Prescribing
Module 2 - CTD Summaries (Quality Overall Summary, Nonclinical & Clinical Overview)
Module 3 - Quality (S part - DMF & P Part - Finished
Module 4 - Nonclinical Study Reports (Literature-Based
Module 5 - Clinical Study Reports (Literature-Based)
Writing / Review
> Registration Application & Covering Letter
> Letter of Authorization
> Summary of product (SmPC) and Pack Information Leaflet (PIL) or Pack insert
> Label and carton contents
> Global Patent Information and Literature for patented PSUR (Periodic Safety Update Reports)
> Legal & Administrative (GMP, CoPP, FSC etc) Expert Summaries
> Site Master File (SMF)
Supportive Services
> Handling all MoH Queries (till product registration) and Review dossier as per Updated MOH guideline
> Advising on translation
> Agreements Writing & Review (CDA/NDA & Supply) DMF (in CTD format)
> Advice on BE studies
> Drafting Process validation, Stability, PDR & AMV
> More than 600 CTD Dossier templates (Ready-to-write : to save time)
> Reference Dossiers / DMFs/ BE Database
ACTD Dossier
Format : Asean ctd guideline
Part I - Administrative Information and Product Information
Part II - Quality (S part - DMF & P Part - Finished Product)
Part III - Nonclinical Study Reports (Literature-Based)
Part IV - Clinical Study Reports (Literature-Based)
Writing / Review
> Registration Application & Covering Letter
> Letter of Authorization
> Summary of product (SmPC)
> PIL or Pack insert
> Label and carton contents
> Legal & Administrative (GMP,CoPP, FSC etc.) Documents
> Expert Summaries
> Site Master File (SMF)
> Process validation, Stability, PDR & AMV, BE
Supportive Services
> Handling all MoH Queries (till product registration)
> Review Dossier as per Updated ASEAN guideline
> Agreements (CDA/NDA & Supply) Writing & Review
> Separate DMF (in CTD / ACTD format)
> More than 600 ACTD Dossier templates (Ready-to-write : to save time)
> Reference ACTD Dossiers / DMFs / BE Database
ROW Dossier
> Format : Asean ctd guideline
> Administrative and legal Part
> Quality Part
> Clinical and Toxicity Part
Writing / Review
> Registration Application & Covering Letter
> Letter of Authorization
> SmPC, PIL or Pack insert
> Label and carton contents
> Legal & Administrative (GMP, CoPP, FSC etc) Documents
> COA, MOA and Specification of Active,
> Non-active and Finished Product
> Process validation, Stability, PDR & AMV,
> BE studies
> BMR / MFR
> Clinical and Toxicity studies
Supportive Services
> Handling all MoH Queries (till product registration)
> Review Dossier as per Updated MOH guideline
> Agreements Writing & Review
> Separate DMF (in CTD format)
> Reference Dossier templates (updated) - For more than 60 country specific templates (Ready-to-write : to save > time)
> Reference Dossiers / DMFs / BE – Database
OPEN PART: DMF
Format : CTD (Common Technical Document)
CTD Introduction
Quality Overall Summary
S.1 General Information
S.2 Manufacture (ROS)
S.3 Characterization
S.4 Control of Drug Substance
S.5 Reference Standards or Materials
S.6 Container Closure System
S.7 Stability
Writing / Review
> Registration Application, Letter of Authorization & Covering Letter
> Legal & Administrative Documents
> Transmittal letter
> Global Patent Information and Literature for patented API
> Patent infringement analysis
> Quality Summaries, Manufacturing and Characterization part of DMF
> Process validation, AMV & Stability Studies
> Specification, Method of analysis & Certificate of Analysis of Raw materials
> Specification, Method of analysis & Certificate of Analysis of API
Advantages Of Our Consultancy
> Experienced Team – Our consultants had vast experience in DMF preparation and review
> Our consultants - previously worked in Top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc.
> Handling all MoH Queries related to DMF (till product registration)
> DMF review as per CTD
> More than 1200 CTD DMF templates (Ready-to-write : to save time)
> Reference US & EU – 600 DMFs
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CLOSED PART : DMF
Format : CTD (Common Technical Document)
Upon request we can also give DMF in ACTD format
S.2 Manufacture
S.2.1 Manufacturer (s)
S.2.2 Description of Manufacturing Process and Process Controls
S.2.3 Control of Materials
S.2.4 Controls of Critical Steps and Intermediates
S.2.5 Process Validation and/or Evaluation
S.2.6 Manufacturing Process Development
Writing / Review
> Registration Application, Letter of Authorization & Covering Letter
> Legal & Administrative Documents
> Transmittal letter
> Global Patent Information and Literature for patented API
> Patent infringement analysis
> Quality Summaries, Manufacturing and Characterization part of DMF
> Process validation, AMV & Stability Studies
> Specification, Method of analysis & Certificate of Analysis of Raw materials
> Specification, Method of analysis & Certificate of Analysis of API
Advantages Of Our Consultancy
> Experienced Team – Our consultants had vast experience in DMF preparation and review
> Our consultants - previously worked in Top Indian companies like DFL, Mylan, Sun Pharma, Ranbaxy, Cipla, Lupin etc.
> Handling all MoH Queries related to DMF (till product registration)
> DMF review as per CTD
> More than 1200 CTD DMF templates (Ready-to-write : to save time)
> Reference US & EU – 600 DMFs
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