Regulatory-Ready Dossiers. Data-Driven Stability
Accelerate your path to approval with our regulatory expertise. We provide comprehensive dossier preparation and ICH-compliant stability studies to support global registrations and ensure your product’s safety, efficacy, and shelf-life.
Dossiers & Stability Studies
At Humanaquest, 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
- Non‑clinical and clinical summaries & overviews
- Translation support and multilingual indexing
- Quality section: description, manufacture, controls of drug substance & product
- Formatting, bookmarking & validation for EMA, FDA, CDSCO submissions
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
- Periodic sampling and analytical testing (assay, degradation, impurities)
- Stability report writing and shelf‑life determination
- GMP‑compliant stability chambers (–20 °C to +40 °C, 25–75 % RH)
- Statistical evaluation and trend analysis
Regulatory Support
Our regulatory affairs team ensures your dossier and stability data meet the expectations of health authorities worldwide.
- Gap analysis & regulatory strategy planning
- Response to queries and deficiency follow‑up
- Pre‑submission meetings and scientific advice
- Post‑approval stability commitments