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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.
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