We Provide Free Consultation For Pre-product Registration / Pre- pharmaceutical Dossier Preparation Inquiries. We take a Multi-Faceted Approach to Medical Device Distribution Management.
Services / Our expertise:
“Regulatory Services – Semi-Regulated Markets”
Regulatory Services – Regulated Markets”
Dossier compilation in CTD format for :
Expert Reports – Quality, Pre-clinical, Clinical
Overviews - Clinical / Non-Clinical (Module 2)
Liaison for Process Validation, Analytical Validation, Stability Studies, Analytical Report, Impurity profile, Development of analytical method, Dissolution profile and related reports Reports on Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity. Liaison for Bioavailability / Bioequivalance Studies, Clinical trials report and related reports for CTD, Geneva, TGA – Australia, Medsafe – New Zealand and Brazil – ANVISA . Drug master file (DMF) compilation for open and closed parts.
Dossier compilation as per:
> Asean Common Technical Dossier (ACTD) Guidelines
Dossiers compilation for submissions in:
> Asia
> Africa
> Central America
> South America
> North America
> CIS countries
Dossier compilation in CTD format for:
> South East Europe
Drug master file (DMF) compilation for open and closed parts
Our area of expertise
Data base of regulatory requirements of more than 100 countries & for more than 5000 molecules. Speedy compilation of Dossiers for Regulated and Semi Regulated markets.
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Regulatory submissions, Liaison with Regulatory boards and follow-ups.
* Complete regulatory support till the registration stage.
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Reports on Bioavailability / Bioequivalance Studies, Clinical Trials studies boards and follow-ups.
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Draft data for Process Validation, Analytical
* Prepare Periodic Safety Update report (PSUR) to fulfill CIS registration dossier requirements.
* Prepare Summary of product (SPC), Pack Insert, Product rationale to fulfill registration dossier requirements.
* Expert Reports – Quality, Pre-clinical, Clinical to fulfill CTD registration dossier requirements.
* Overviews - Clinical / Non-Clinical to fulfill CTD registration dossier requirements.
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Liaison for Process Validation, Analytical Validation, Stability Studies and related reports.
*
Reports on Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity.
*
Liaison for Bioavailability / Bioequivalance Studies, Clinical trials report and related reports for CTD, Geneva, TGA – Australia, Medsafe – New Zealand and Brazil – ANVISA .
* Dossier conversion (from one country to another)
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Registration Assistance.
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Drug master file (DMF) compilation for open and closed parts.
Asean Common Technical Dossier (ACTD) Guidelines
