Our associate animal toxicological study centers are providing preclinical studies services to fulfill requirements of registration dossier.
Toxicity studies:
Acute Toxicity
Subchronic Toxicity
Chronic Toxicity
Carcinogenicity
Mutagenicity
Reproduction /Teratology Studies etc.
Median lethal dose (LD 50)
Format And Guideline:- As per country specific guideline.
Dossier compilation as per:
> 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
Dossier compilation in CTD format for:
> South East Europe
>
South west Europe
Drug master file (DMF) compilation for open and closed parts
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.