RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
Format : EU / WHO / Country specific guideline
PDDS encompass a pool of native & international translators specialized in regulatory domains to ensure the successful completion of your dossier registration on time and on budget while providing you with a superior quality of service
Our Language handling capabilities are not limited to the below :-
European (Albanian, Algerian, Bosnian, Bulgarian, Belarusian, Basque, Croatian, Creole, Catalan, Cebuano, Czech, Danish, Dutch, Estonian, English, French, Finnish, Flemish, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Macedonian, Maltese, Norwegian, Polish, Portuguese, Romanian, Russian, Spanish, Swedish, Serbian, Slovak, Slovenian, Turkish, Turkmen, Ukrainian etc.,)
Asian (Burmese, Bangladeshi (Sylheti), Cambodian (Khmer), Chinese (Simplified and Traditional), Indonesian, Japanese, Korean, Lao, Malay, Mongolian, Pashto, Singhalese, Taiwanese, Tagalog (Filipino), Thai, Tibetan, Vietnamese)
Middle East and African Languages (Arabic, Armenian, Dari, Farsi, Hebrew, Kurdish (Sorani), Moroccan, Syrian, Tunisian, Uzbek, Amharic, Hausa, Tigrinya, Malagasy, Nigerian, Somali, Swahili, Yoruba, Zulu)
We perform Comparative in vitro dissolution testing and also provide report. It can use in case of biowaiver.
Three major factors that govern the rate and extent of drug absorption from immediate release (IR) solid dosage forms are the dissolution of the drug product, and the aqueous solubility and intestinal permeability of the drug substance. The Biopharmaceutical Classification System (BCS) classifies the active substance into one of four classes, depending on the level of solubility and the level of permeability. Combination of the dissolution of the drug product with the BCS classification of the drug substance provides the possibility to waive in vivo bioequivalence studies for certain categories of IR drug products.
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