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.
Profile
Headquartered in Mumbai, India, Labela Regsources, is a provider of complete solution on Regulatory Affairs to Pharmaceutical 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.
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
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.