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Profile

Headquartered in Mumbai, India, Labela Regsources, is a provider of complete solution on Regulatory Affairs to Pharmaceutical Pharma Product Registration India

companies wanting to introduce products into global markets. Established in 1997, The company is headed by Rita Gada, a pharmacist with over 15 years of experience in the field of Global Regulatory Affairs. The team at Labela consists of well qualified and dedicated staff with rich experience of dossier compilation and regulatory filings across global drug authorities.

Labela Regsources offers supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Registering Pharmaceutical Dossier Writing. Labela has been involved with all aspects of regulatory affairs, from supporting clinical trials, bioequivalence reports, validation data through registration activities, compilation of Pharmaceutical dossier / application for registrations of medicines and E-Filings to post-marketing regulatory obligations for Pharma Industry.

Labela Regsources has a rich experience of providing services across therapeutic segments (including animal health and herbal products) and has registered more than 5000 products in over 100 countries.

Labela Regsources has a specialized division that helps medical device manufacturers research, analyze, select and manage Indian medical device distributors.

With a team of experienced professionals on-site Indian we can help you obtain fast and cost effective access to the Indian market.

We take a multi-faceted approach to medical device distribution management. The goal is to ensure that all potential medical distribution partners in Indian are objectively evaluated based on your business needs, and carefully monitored afterwards for ongoing success.

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.