Studies &
Case Studies

Overview

Comprehensive assessment of drug-container interactions for parenteral, inhalation, and ophthalmic products. Identifies organic and inorganic compounds that may migrate from packaging into drug products.

Regulatory Framework

USP <1663>, USP <1664>, ICH Q3E, BioPhorum, PQRI Guidelines

Key Aspects

Overview

Long-term, accelerated, intermediate, and stress stability studies for APIs and drug products. Supports shelf-life determination, regulatory submissions, and formulation development.

Regulatory Framework

ICH Q1A(R2), ICH Q1B, ICH Q1C, ICH Q1E, ICH Q5C

Key Aspects

Overview

In-Vitro Release Testing and In-Vitro Permeation Testing for topical semi-solid products. Supports bioequivalence studies, SUPAC changes, and formulation optimization.

Regulatory Framework

FDA SUPAC-SS, EMA Topicals Guidance, USP <724>, FDA BE Guidance

Key Aspects

Overview

Risk-based assessment and testing of 24 elemental impurities in pharmaceutical products per ICH Q3D. Covers all routes of administration with appropriate PDEs.

Regulatory Framework

ICH Q3D, USP <232>, USP <233>, EP 5.20

Key Aspects

Overview

Highly sensitive detection and quantification of nitrosamines and NDSRIs in APIs and drug products. Supports FDA/EMA nitrosamine risk assessment and control strategy development.

Regulatory Framework

FDA Nitrosamine Guidance, EMA Guidance, ICH M7, ICH Q3B

Key Aspects

Overview

Comparative dissolution profiling, multimedia dissolution, and method development for solid oral dosage forms. Supports bioequivalence submissions, SUPAC changes, and biowaiver applications.

Regulatory Framework

USP <711>, ICH Q6A, FDA Dissolution Guidance, EMA Dissolution Guidance

Key Aspects