Validation Protocol

Bio-Equivalence:
The Therapeutic Identity

Engineering therapeutic identities that mirror innovation in every clinical metric.

Defining Therapeutic Equivalence

At INVIVO, our mission of affordability is anchored in the highest levels of scientific validation. We don't just develop alternatives; we engineer therapeutic identities.

Our Bio-equivalence (BE) studies are the definitive proof that our formulations deliver the exact same clinical efficacy, safety profile, and performance as the innovator products.

The Rigour of Our Methodology

Our process is governed by a "Zero-Deviation" philosophy:

Pharmacokinetic Precision (PK)

Measuring Cmax and AUC with surgical accuracy to ensure our formulations achieve the same rate and extent of absorption as the innovator.

In-Vitro/In-Vivo Correlation (IVIVC)

Leveraging bio-predictive modelling to ensure speciality medicines behave predictably within the human body.

Global Regulatory Alignment

Meeting and exceeding stringent FDA, EMA, and international requirements for global market entry.

Bridging the Gap: Innovation Meets Affordability

We view Bio-equivalence as the bridge between "High-Cost Innovation" and "Universal Access."

By proving that our formulations are bio-equivalent to the innovator, we eliminate the clinical risk for healthcare providers while drastically reducing the financial burden on patients.

Independent CRO Partnerships: To ensure total objectivity and transparency, all studies are conducted through elite, globally-audited Clinical Research Organisations (CROs).

The INVIVO Guarantee

"Performance Without Compromise: stress-tested against the global gold standard."

Affordable and Identical are one and the same

Bio-Equivalence:The Therapeutic Identity