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The One Stop For all Your Regulatory Requirements

Forth Coming Events : Stall at CPHI – Paris (World Wide) - IP 12 ; Forth Coming Events Stall at CPHI – India – G-43

Regulatory Submissions

Our Representative render the following services in respective countries :

Countries - Vietnam, Cambodia, Mynamar, kenya, Uganda, Tanzania, GCC countries – Saudi Arabia, Kuwait, Bahrain, Qatar, UAE, Oman, Yemen. CIS countries – Kyrgyzstan, Uzbekistan, Turkmenistan, Georgia, Tajikistan, Belarus, Kazakhstan, Azerbaijan, Ukraine, Russia.

Render the following Services
> Company registration.
> Brand search.
> Preparing the dossier in English and respective languages.
> Handling query if any on your behalf.
> Get the registration of pharmaceutical product.

Countries

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

Asia
Bangladesh Bhutan Cambodia Hongkong Indonesia Iran Iraq Jordan	Lebanon Malaysia Mongolia Myanmar Nepal Paksitan Papuanew guinea Philippines	Saudi Arabia Singapore Srilanka Syria Thailand Turkey Vietnam Yemen

Africa
Algeria Botswana Burkina Faso Cameroon Chad Congo Egypt Ethiopia Gambia Ghana Ivory coast	Kenya Madagascar Malawi (Nyasaland) Mali Mauritania Mauritius Mozambique Namibia Niger Nigeria	Senegal Sierra leone Sudan Tanzania Togo Tunisia Uganda Zaire Zambia Zanzibar Zimbabwe

Central America
Costarica Cuba Dominican Republic Elsavador	Guatemela Haiti Hondurus Jamaica	Nicaragua Panama Trinidad

South America
Argentina Bolivia	Chile Ecuador	Guyana

North America
Mexico Peru	Suriname Uruguay	Venezuela

CIS countries
Azerbaijan Belarus Estonia Georgia	Kazakhstan Kyrgyzstan Russia Tajikistan	Turkmenistan Ukraine Uzbekistan

South Africa ( MCC - MRF1 )


South East / West Europe (CTD format)
Bulgaria	Romania	Spain

Other specific country
Moldova	Armenia

Dossier compilation as per:

> Common technical dossier (CTD) format
> Asean Common Technical Dossier (ACTD) Guidelines > South Africa (MCC-MRF-1) Guidelines.
> Brazil ANVISA Guidelines

Dossiers compilation for submissions in:

> Asia
> Africa
> Central America
> South America
> North America
> CIS countries

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

> Expert report
> Overview - Clinical / Non-
clinical
> Periodic Safety Update
report (PSUR)
> Validation
> Bioequivalence Studies
> Clinical Trial Report

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.

* 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.