Regulatory-focused BE planning
Planning a generic product registration in the GCC or Jordan may require more than identifying a laboratory that can perform a bioequivalence study. Study requirements, the selected center, reference-product strategy, timelines and commercial terms should be assessed before study initiation.
ViaFarma's role
ViaFarma assesses the likely requirement, facilitates access to qualified and approved BE centers, coordinates quotations and supports regulatory-focused planning. The selected BE center or CRO—not ViaFarma—conducts the study.
Regulatory-led center access
Access to Approved BE Centers
ViaFarma facilitates access to Bioequivalence study centers that are listed among approved GCC laboratories and approved by the Jordan Food and Drug Administration (JFDA). Our role is to help manufacturers identify an appropriate study option based on the product, intended registration market, regulatory requirements, technical considerations, timeline and commercial objectives.
From assessment to coordination
How ViaFarma Supports You
BE Requirement Assessment
Review the molecule, strength, dosage form, target market and intended registration pathway to understand the likely BE requirements.
Suitable BE Center Identification
Identify suitable BE study options through ViaFarma’s network of qualified and approved centers.
Technical & Commercial Quotation Coordination
Coordinate the information required to obtain meaningful technical and commercial proposals.
CRO Option Comparison
Support comparison of quotations, study scope, timelines and relevant technical and commercial considerations rather than selecting solely on price.
Reference / Comparator Planning
Support early consideration of reference or comparator product requirements in the context of the intended regulatory pathway.
Study Coordination
Facilitate communication and coordination between the pharmaceutical manufacturer and the selected BE center as the project progresses.
A development and regulatory decision
The Cheapest BE Quote Is Not Always the Lowest-Cost Decision
A BE study should not be evaluated on study price alone. An unsuitable study approach, incorrect assumptions regarding the target market, reference product issues, incomplete technical scope or regulatory misalignment can create delays, additional studies or unnecessary development costs. ViaFarma helps manufacturers assess the BE requirement and available study options before committing to a CRO.
Start with what is available
Planning a BE Study?
To start the assessment, send ViaFarma the available information for your product. If some information is not yet available, your company may still contact us for an initial assessment.
Request BE Study Support- Molecule / active ingredient
- Strength
- Dosage form
- Target registration market(s)
- Intended indication, where relevant
- Available product development information
- Proposed reference/comparator product, if already identified
Within ViaFarma's market-entry model
Where BE Planning Fits
BE planning is one component of a broader regulatory and market-entry strategy. ViaFarma helps connect technical development decisions with the intended registration pathway.
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Read ViaFarma’s analysisQuestions from manufacturing and regulatory teams
When should bioequivalence study planning begin?
EDE lists bioequivalence where required for its marketing authorization process. ViaFarma recommends reviewing the evidence route during development, before locking the study protocol or commissioning a CRO. Check the reference product strategy, test batch, study design and center suitability for each intended market.