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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.

Services / Our expertise:

Technical Reach

Dosage Form

Therapeutic Areas

Medical Devices


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.

Market Entry Research

We can research the sales potential for your medical devices in specific states or geographic regions and tell you which of your competitors are strongest in those markets.

Related Services

In addition to medical device distribution consulting, we can assist you with regulatory compliance, logistics and warehousing, reimbursement, document translations and other related services.

 Distribution Management

Once distribution partners have been established, we can act as your local liaison to ensure mutual long term success.
We fully customize this service to fit your needs. If an ocean and/or language separates you and your distributors in a particular market, we also highly recommend using our ongoing medical distribution management services. In this capacity, we can act as the local liaison between your company and your medical distribution partners, performing services such as :

  • Acting as the liaison between your company and the medical distribution partners (both distributors and logistics and other service providers).
  • Providing assistance with troubleshooting.
  • Regularly contacting your medical distribution partners to conduct marketing audits.
  • Monitoring the marketplace for any new competing products.
  • Measuring distributor performance and providing quarterly reports on sales volume and service levels.
  • Tracking medical distribution partner promotional activities (trade show attendance, mailings, advertising, etc.).
  • Regularly contacting your logistics and other service providers to conduct quarterly performance audits measuring sales volume and service levels.

Medical device distribution management is an annual renewable service that can be fully customized to suit your needs and is typically done on a commission basis.

 
 
 
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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