IFaB

About IFaB

Investigación Farmacológica y Biofarmacéutica S.A. de C.V. (IFaB) is a Contract Research Organization (CRO) specializing in bioavailability and bioequivalence studies within the Mexican pharmaceutical market. The company operates as an Authorized Third Party, a designation created by Mexican health law that allows private entities to assist the national regulatory authority, COFEPRIS, in its functions. This role involves pre-revising submission dossiers for drug registrations, which helps to accelerate the review and approval process.

IFaB provides services to both international and domestic pharmaceutical companies. The company is certified by Mexico's Federal Commission for the Protection against Health Risks (COFEPRIS) and holds a certification from the Brazilian National Health Advisory Agency (ANVISA), making it the only Mexican company with this dual certification. This allows a single bioequivalence study conducted by IFaB to potentially meet the regulatory requirements for market licenses in Mexico, Brazil, and several other Latin American countries, covering a significant portion of the regional market. The business model is centered on conducting clinical trials, particularly bioavailability and bioequivalence testing, which are essential for the registration of generic drugs. The demand for these studies increased significantly following new regulations in Mexico aimed at renewing legacy drug licenses.

As an Authorized Third Party, IFaB shares responsibility with the pharmaceutical laboratory to ensure products meet the standards set by COFEPRIS, undertaking a thorough review process. The use of such third parties is an optional, alternative pathway for pharmaceutical companies to navigate the regulatory landscape, designed to make the work of the health authority more efficient. This model is unique to Mexico, positioning companies like IFaB as private-sector extensions of the government's regulatory function.