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.
An ISO 9001:2015 certified and WHO-GSDP compliant company.
Dossiers & Stability Studies
At WPI Pharma, 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