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Business Consultancy

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Dossier Services

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Medical Writing & Clinical Studies

Bioavailability / Bioequivalence / Clinical Trial Studies

Analytical Solutions

Preclinical / Non clinical / Toxicological Studies

Our area of expertise

Compilation of dossier as per latest country specific guidelines

Ω  Dossier compilation as per :
       • Asean Common Technical Dossier (ACTD)          Guidelines.
       • South Africa (MCC-MRF-1) Guidelines.
       • Brazil ANVISA Guidelines.

Ω  Dossiers compilation for submissions in :
       • Asia
       • Africa
       • Central America
       • South America
       • North America

Ω  Dossier compilation in Common Technical      Dossier (CTD) format for
       • Commonwealth of Independent States
         (CIS) Guidelines.
       • South East / West Europe Guidelines.

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

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Ω  Drafts data for
       • BMR, MFR
       • Process Validation,
       • Stability Study reports,
       • Dissolution profile,
       • Certificate of analysis and related reports

Ω  Reports on
       • Bioavailability / Bioequivalance Studies,
       • Clinical Trials studies
       • Justification for fixed dose combination
       • Prepare Periodic Safety Update report          (PSUR).
       • Preclinical studies like Toxicity,          Carcinogenicity, Teratology & Reproduction          toxicity.

Ω Prepare Summary of product (SPC), Pack      Insert, Product rationale.

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Ø  Expert Reports
       • Quality,
       • Pre-clinical,
       • Clinical

Ø  Overviews (Module 2)
       • Clinical
       • Non-Clinical

Ø  Nonclinical Study Reports(Module 4)

Ø  Clinical Study Reports(Module 5)

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Ω Ready dossiers available in ACTD, CTD, Asian, African, CIS, Central America, South America, North America.

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Ω Dossier conversion (from one country to another)

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Ω Registration Assistance

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

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Disclaimer

All information and material in this site are provided on an "as is" basis, and are without guarantees or warranties of any kind, express or implied. Furthermore, any ideas and/or information provided or gained from this site would not necessarily reflect the views of Labela Regsources or its directors or employees.

The materials and/or information available or obtained at/through this site is/are not guaranteed or warranted in terms of completeness, correctness, accuracy, reliability or otherwise howsoever by Labela Regsources or its directors or employees.

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Under no circumstances, including but not limited to negligence, shall Labela Regsources or its directors or employees be liable for any special or consequential damages that are alleged to have resulted from the use and/or inability to use this site or information contained within, even if Labela Regsources and/or its employees or directors have been notified of the possibilities of potential damages or losses.

In no case shall Labela Regsources or its directors or employees be liable to any person or entity for any damages or losses resulting either directly or indirectly from accessing this site. The information provided herein and any communications subsequently entertained or responded to are/shall be gratis an are/shall be outside the purview of any consumer protection law. Any recipient or user of any information or material in this site may use/rely upon the information or material entirely at his/its own risk.

The contents of this site shall not be reproduced, distributed or published in whole or in part by the recipient hereof or any other person for any purpose without the prior written approval of Labela Regsources.


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