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.
We also have active association with approved study centers with state of art facilities to perform BA/BE studies (single dose, multiple dose, 2-way, 3-way, replicate design & dose proportionality studies, immediate and modified release, various dosage forms of known molecules) as well as Phase I, II, & III clinical studies (CTR).
Bioequivalence studies is a science based regulatory affairs project which includes a combination of studies based on specialization. The main aim is to establish if rate and extent of absorption of the given sample of the drug is comparable with innovators formulation.
Our Strengths Tie Up with well established study centers to carry out BA/BE/Clinical Studies.
We add value by Helping clients carry out BA/BE/CTR studies in well established study centers, which are approved from local DCGI and international WHO, EU, US FDA, Geneva, TGA – Australia, Medsafe – New Zealand and Brazil – ANVISA.
Format And Guideline:- As per country specific guideline.
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.
