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Registration

Projects for registration in foreign markets

We Labela Regsources ourselves in undertaking registration activities for various organizations.

Labela Regsources undertakes projects from organisations where in it handles their registration process by including activities like dossier preparation, sampling and arranging legal documents required for registering their products of the desired country upto the stage of handing over registration certificate to the brand owners.

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.

* Regulatory submissions, Liaison with Regulatory       boards and follow-ups.

*    Complete regulatory support till the registration       stage.

*    Reports on Bioavailability / Bioequivalance Studies,       Clinical Trials studies boards and follow-ups.

*    Draft data for Process Validation, Analytical
   Validation, Stability Studies report, Dissolution       profile, Certificate of analysis and related reports.

*   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.

*   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)

*    Registration Assistance.

*    Drug master file (DMF) compilation for open and       closed parts.