Dossiers & Stability Studies
At GNH India, we deliver comprehensive dossier preparation and stability study services to support global regulatory submissions and ensure your product’s quality throughout its lifecycle.
From compiling CTD‑ready modules to designing ICH‑compliant stability protocols, our multidisciplinary team combines technical expertise with practical experience to streamline your approval process.
Dossier Preparation
- Compilation of Module 1–5 in CTD/eCTD format
- Quality section: description, manufacture, controls of drug substance & product
- Non‑clinical and clinical summaries & overviews
- Formatting, bookmarking & validation for EMA, FDA, CDSCO submissions
- Translation support and multilingual indexing
Stability Studies
We design and execute stability programs in accordance with ICH Q1A(R2) guidelines, covering long‑term, accelerated, and stress conditions.
- Protocol development and study design
- GMP‑compliant stability chambers (–20 °C to +40 °C, 25–75 % RH)
- Periodic sampling and analytical testing (assay, degradation, impurities)
- Statistical evaluation and trend analysis
- Stability report writing and shelf‑life determination
Regulatory Support
Our regulatory affairs team ensures your dossier and stability data meet the expectations of health authorities worldwide.
- Gap analysis & regulatory strategy planning
- Pre‑submission meetings and scientific advice
- Response to queries and deficiency follow‑up
- Post‑approval stability commitments