BE/Biowaiver Strategy And Clinical/Non-Clinical Modules

BE/Biowaiver Strategy

BE/Biowaiver Strategy & Clinical/Non-Clinical Modules

Why It Matters

Bioequivalence (BE) studies and Biowaiver strategies are critical for generics and certain formulations to gain approval without full-scale clinical trials. Robust clinical and non-clinical documentation ensures regulatory acceptance and faster approvals.

Our Expertise

We design scientifically sound and regulatory-compliant BE/biowaiver strategies, while also preparing clinical and non-clinical modules aligned with ICH and regional guidelines.

Our Services Include

BE Study Design & Protocol Development

Tailored strategies to meet FDA, EMA, and other agency expectations.

Biowaiver Justifications

Based on BCS classification and regulatory frameworks.

Clinical/Non-Clinical Module Preparation

Writing, reviewing, and compiling Modules 2.4, 2.5, 2.6, and 2.7.

Regulatory Interactions

Support in addressing agency questions and deficiency letters.

Our Global Solutions

Product Selection & Development Strategy

A strong product selection and development strategy ensures that your product is not only technically feasible, but also meets unmet market needs, regulatory requirements, and commercial viability.

eCTD Dossier Preparation & Global Submissions

The electronic Common Technical Document (eCTD) is the standard format for submitting regulatory dossiers across global agencies.

Regulatory Strategy, Gap Analysis & Market Access Support

A strong regulatory strategy ensures your product development aligns with global requirements from day one. Gap analysis helps identify missing or weak areas early, saving time, cost, and reducing approval risks.

MA Holding (EU/UK/US)

Entering regulated markets like the EU, UK, and US requires a local Marketing Authorization (MA) holder to ensure compliance with complex regulations. Having a trusted MA holder allows your products to reach patients

Batch Release, Batch Testing & Warehousing Support

Ensuring the quality, safety, and timely availability of pharmaceutical and healthcare products is critical for regulatory compliance and patient safety. Proper batch testing, release procedures, and secure warehousing

BE/Biowaiver Strategy & Clinical/Non-Clinical Modules

Bioequivalence (BE) studies and Biowaiver strategies are critical for generics and certain formulations to gain approval without full-scale clinical trials.

QPPV / Pharmacovigilance Support

Pharmacovigilance is a regulatory obligation and a patient safety priority. Every Marketing Authorization Holder in the EU/UK must appoint a Qualified Person for Pharmacovigilance (QPPV) to oversee drug safety and risk management.

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