Expert comparator & biowaiver testing
Accelerating development through comparative and biowaiver strategies
Establishing the comparative performance of a drug product is a pivotal step in its development journey. Whether supporting a generic application, a reformulated product, post-approval changes, or lifecycle management activities, comparative testing and BCS-based biowaiver studies play a critical role in generating the evidence required by regulators.
Eurofins BioPharma Product Testing provides the analytical expertise, regulatory insight, and global laboratory network needed to support both comparator product evaluations and biowaiver programs. From comparative dissolution and stability studies to solubility profiling and BCS classification support, we generate high-quality, submission-ready data aligned with regulatory agencies' expectations.
By combining scientific excellence with a strategic regulatory approach, we help drug developers reduce risk, accelerate timelines, and build strong evidence packages that support successful regulatory submissions.
Comparator product testing
A comparator, also called an active control, is an investigational or marketed product used as a reference standard in a clinical trial. In many late-phase studies, it represents the current approved standard of care: the ‘gold standard’ against which a new investigational medicinal product (IMP) is measured. Regulators (FDA/EMA) require an active control in Phase III trials to demonstrate a new drug’s true benefit to patients.
Your development challenges are unique. Our experts act as scientific problem-solvers, working alongside you to uncover meaningful insights and reduce uncertainty.
We combine deep analytical expertise with practical regulatory understanding to enable you to:
- Navigate complex comparator requirements
- Address product-specific challenges
- Translate analytical results into clear development decisions
Comprehensive testing & methods for your product
We design our services to support you at every stage of comparator testing, from early development through regulatory submission.
Our expertise includes:
- Depth of therapeutic expertise: Experience with more than 100 marketed drugs across various therapeutic areas, from anti-inflammatories and antidepressants to antiretrovirals.
- Strategic method development: When no suitable pharmacopeial method exists, we develop de novo methods from first principles, including the selection of discriminatory dissolution media.
- Forced degradation & specificity: Since innovator placebos are rarely available, we use PDA detection and forced degradation to "stress" the product. This proves no excipient is hiding an impurity, ensuring a clean, defensible analytical package.
- Phase-appropriate validation: Method validation as per ICH Q2(R2) and ICH Q14, covering specificity, repeatability, accuracy, and solution stability to meet strict regulatory expectations for early-phase through commercialisation.
Our test methods
Whether you are preparing a generics submission or comparative clinical study, Eurofins BPT offers:
- Access to global comparator product inventories
- GMP-compliant testing environments
- In-depth regulatory expertise
- Rapid turnaround times and transparent online data access
Comparative dissolution: comparative dissolution profiling across pH 1.2, 4.5 and 6.8 media with f₂ similarity factor calculation, supported by scientific guidance to help clients interpret results within their regulatory strategy.
Stability studies that strengthen your submission: Stability testing is a cornerstone of the regulatory submission process. For blinded or over-encapsulated products, regulators require definitive proof that the drug remains stable and efficacious within its new secondary packaging throughout the duration of the clinical trial.
We help you generate robust, submission-ready stability packages by offering:
Established stability facilities: our global network features state-of-the-art, high-capacity stability suites capable of supporting all major climatic zones.
ICH-compliant protocols: we design and execute protocol-based stability studies in strict accordance with ICH Q1A (R2) guidelines.
End-to-end oversight: we manage the entire stability lifecycle for comparators, from protocol design and sample storage to pull-point testing and final reporting.
Submission-ready data: our stability data packages are designed to withstand the rigors of FDA and EMA review, providing the necessary assurance that the comparator’s quality remains uncompromised.
BCS-based biowaivers testing
In today’s competitive pharmaceutical landscape, speed‑to‑market is everything. BCS based biowaivers offer one of the most powerful opportunities to cut months from development timelines by replacing expensive in ‑vivo bioequivalence (BE) studies with high‑quality in‑ vitro analytical testing.
Eurofins BPT helps you unlock this opportunity — transforming regulatory complexity into a fast, efficient approval strategy.
Our integrated scientific and regulatory expertise helps you:
- Avoid unnecessary clinical studies and reduce costs
- Accelerate regulatory approvals for generics and lifecycle management
- Ensure compliance with ICH M9
- Reduce project risk through precise solubility and dissolution testing
We convert complex BE challenges into clean, defensible analytical packages that satisfy regulators worldwide.
Understanding the biowaiver pathway
Biowaiver eligibility is determined primarily by a drug’s aqueous solubility and classification within the BCS framework.
BCS eligibility overview
| BCS Class | Properties | Biowaiver potential |
| Class I | High solubility/ high permeability | Highly preferred by major regulators. |
| Class II | Low solubility / high permeability | Selective cases (e.g., Ibuprofen) |
| Class III | High solubility / low permeability | Eligible with strict excipient & dissolution controls |
| Class IV | Low solubility / low permeability | Emerging acceptance in limited cases (e.g., Who) |
The WHO and some international agencies have broadened the scope, while FDA and EMA remain primarily focused on Class I and Class III drugs.
Global regulatory alignment: navigating ICH M9 and regional nuances
While ICH M9 is driving harmonisation, regional nuances still matter. For example:
- FDA bases solubility on the highest dose strength
- WHO/EMA use the highest therapeutic single dose
Eurofins BPT ensures complete alignment across all major markets, including FDA, EMA, WHO, and key Latin American authorities.
We support biowaiver strategies for:
- Generic submissions
- SUPAC / post‑approval changes
- Pediatric and geriatric formulations
Technical excellence: solubility & dissolution the core of biowaiver success
Eurofins BPT executes all required BCS and dissolution studies with the precision needed for regulatory approval.
Solubility profiling
- API must dissolve completely in ≤250 mL across pH 1.2–6.8
- Evaluated at multiple pH conditions using validated methods
- Tests performed in triplicate to ensure reliability
Dissolution performance
- Class I drugs: ≥85% dissolution within 30 minutes
- Class III drugs: ≥85% dissolution within 15 minutes
- If not achieved, dissolution similarity must be demonstrated using f₂ comparisons
These rigorous in‑vitro evaluations provide the evidence needed to replace clinical BE studies.