RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
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
With document publishing tasks, accounting for a significant portion of the time spent on eCTD compilation why not let PDDS help. Our team will prepare submission ready documents based on agency requirements (convert your files and take responsibility for activities such as adding bookmarks and checking that external and internal hyperlinks are properly established).
Our comprehensive eCTD services include:
• Project management of all regulatory submissions
• Formatting and editing of regulatory documentation
• Preparation of documents and references for submission
• Verification and insertion of appropriate document hyperlinks
• Initial submission of eCTD, & Drug MasterFile (eDMF) submission and maintenance
• Preparation and publishing of amendments and supplements
• Country-specific composition, publishing, and validation for submissions
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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