Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES

Due to our active involvement in Manufacturing and interaction with various laboratories and manufacturers we are able to undertake Internationally acceptable quality of :

• Stability studies for Zone 4 countries
• BA / BE studies for Pharmaceuticals and Biologicals

Contact our team to learn more about our offerings.

We can conduct BE/BA Studies for domestic and international markets.

Bioavailability Study: From a pharmacokinetic perspective, BA data for a given formulation provides an estimate of the relative fraction of the orally administered dose that is absorbed into the systemic circulation when compared to the BA data for a solution, suspension, or intravenous dosage form.

In addition, BA studies provide other useful pharmacokinetic information related to distribution, elimination, the effects of nutrients on the absorption of the drug, dose proportionality, linearity in the pharmacokinetics of the active moieties and, where appropriate, inactive moieties.

BA data can also provide information indirectly about the properties of a drug substance before entry into the systemic circulation, such as permeability and the influence of presystemic enzymes and/or transporters (e.g. p-glycoprotein).

Bioequivalence Study: As noted in the statutory definitions, both BE and product quality BA focus on the release of a drug substance from a drug product and subsequent absorption into the systemic circulation.

CTD DOSSIER PREPARATION SERVICE:

Over the years our organisation has prepared numerous Dossiers for registering products manufactured by us in several countries.

This has helped us gain valuable insight into Dossier preparation activity.

Our regulatory team is competent and well equipped to prepare eCTD dossiers meeting the most demanding standards of EU / US and other regulated markets.

Needless to say that we are well versed in dossiers for Semi-regulated and unregulated markets as well.