Aligned with the African Medicines Agency's continental BE vision

Africa's Verified Bioequivalence Marketplace — built to strengthen local manufacturing.

African manufacturers still send most bioequivalence studies to Asia and the Middle East — because they can't reliably find, qualify or trust local capacity. Equiva maps, verifies and connects that capacity, so BE data (and the value it creates) stays on the continent.

For African manufacturersPost a BE Requirement For African CROs & BE unitsList Your Centre

5→180+: operational BE centres by 2030
25–40%: cost cut vs. India / Middle East
<25 days: match to first subject (target)

Fasting, 24-subject, immediate-release

Live

Cape Bio Research Unit

Cape Town, ZA · 48 beds · SAHPRA · WHO-PQ

from $88k

indicative

Lagos Clinical Pharmacology

Lagos, NG · 36 beds · NAFDAC · GCP

from $74k

indicative

Nile Clinical Research Unit

Cairo, EG · 60 beds · EDA · SAHPRA

from $92k

indicative

Africa-first · LATAM & Asia rolling outView all →

US-FDA alignedEMA / MHRA alignedWHO PQ pathwaysANVISA · SAHPRA · CDSCOGCP · GLP audited

The problem

African BE data is being generated everywhere except Africa.

Every generic filing needs bioequivalence data. But African manufacturers can't reliably find, qualify or contract local BE centres — so studies get sent to Asia and the Middle East. Cost rises, timelines slip, and the capability, IP and data leave the continent with them.

AMA and its partners have made continental BE support an explicit priority. What's missing is the private-sector infrastructure to make local BE the default — not the exception.

~80%

of African BE studies are still executed offshore — mostly in India, Jordan and the UAE.

5 of 54

African countries have operational, regulator-recognised BE centres today.

6–12 mo

of delay and 30–60% cost premium for manufacturers forced to source BE abroad.

Indicative estimates synthesised from AMA stakeholder consultations, WHO PQ data and industry sources. Equiva is building the primary dataset.

How Equiva helps

Three pillars. One coherent continental BE mechanism.

Each pillar maps directly to what AMA stakeholders have identified as the missing infrastructure: knowing the capacity, guiding the sponsor, and executing the study to a standard regulators can rely on.

Pillar 01

Verified Capacity Map

A living, inspected directory of African BE centres with transparent standards — GCP, GLP/GCLP, bioanalytical method validation, data integrity, volunteer safety.

Continental coverage, country by country
Regulator recognition & inspection history surfaced
Capacity, therapeutic and dosage-form experience

Pillar 02

Manufacturer Guidance Pathway

Practical, plain-language guidance on when BE is required vs biowaiver possible, which verified centres are suitable, and how to reach a submission-ready protocol and report.

BE vs biowaiver decision support
Regulator-aligned protocol templates
Local reference-product handling and sourcing help

Pillar 03

Trusted Matching & Execution

Structured RFQ matching plus built-in tools that reduce duplication and improve acceptance across countries — so one study can support filings in multiple markets.

Matched shortlist of eligible verified centres
Shared execution toolkit: Protocol Studio, Volunteer Ops, BA, eTMF Lite
Reliance-ready dossiers to support cross-country acceptance

Strategic integration

Leveraging Existing African Infrastructure

Equiva is designed to integrate with and accelerate platforms that are already digitizing and strengthening African trial sites like BRIDGE™. By connecting with existing site assessment frameworks and digitized site networks, Equiva can deliver a verified continental BE capacity map much faster while reinforcing — rather than duplicating — ongoing capacity-building efforts.

01 · Marketplace

A directory that actually knows what a BE site looks like.

Every listing carries the fields sponsors actually shortlist on — bed count, dosing history, bioanalytical method library, regulator inspection dates, therapeutic experience, volunteer pool demographics.

Filter by regulator, therapeutic area, study type, capacity, cost band
Verified accreditation & inspection history
Side-by-side capacity comparisons
Tiered listings — free profile through featured placement

Site profile · sample

Verified

Beds

Studies / yr

Volunteer pool

9,400

Assay library

412 methods

Last FDA inspection

2025 · NAI

Currency

USD · INR

Therapeutic strength: CNS, cardiovascular, endocrine, ARV, oncology-oral.

Built for the whole BE ecosystem

One platform. Four sides of the market.

Manufacturers, centres, regulators and investors each get the specific surface they need — connected by the same verified capacity layer.

01 · Manufacturers

For African pharmaceutical manufacturers

Stop losing months and hard currency to offshore BE. Find a verified local centre suited to your molecule and file.

Matched shortlist of qualified African BE centres
Guidance on when BE is required vs biowaiver eligible
Submission-ready protocol and report templates

Post a BE requirement

02 · BE Centres

For bioequivalence CROs & clinical pharmacology units

Get discovered by manufacturers actively looking for African capacity — and run studies on tools built for BE.

Verified profile with capacity, accreditations, therapeutic experience
Inbound RFQs from local and continental sponsors
Volunteer Ops, BA workflow and eTMF Lite included

List your centre

03 · Regulators

For AMA, RECs & national regulators

A private-sector asset that operationalises AMA's continental BE support vision — without AMA having to build the tech itself.

Continental capacity map with transparent verification standards
Reliance-friendly data and site inspection history
Reduced duplication across NRAs and REC pathways

See how we support AMA

04 · Investors & Partners

For investors & development partners

African BE is underbuilt, strategic infrastructure. Track capacity buildout, deal flow and country trajectories.

Quarterly intelligence on capacity and utilisation
Pipeline of investable BE centres seeking growth capital
Co-investment and DFI blended-finance opportunities

Explore intelligence

02 · SaaS Tools

The workflow layer BE sites have been reinventing in spreadsheets.

Modular apps for the operational reality of running BE — priced per site, per seat, or bundled with your marketplace listing.

Protocol Studio

Template-driven BE protocol authoring with regulator-specific checklists (FDA, EMA, WHO-PQ, ANVISA, CDSCO).

Volunteer Ops

Recruitment, screening, dosing schedules and reimbursement — GDPR / POPIA / LGPD-ready by default.

BA Workflow

Method validation trackers, chain-of-custody, ISR handling, and instrument QC logs designed for BA labs.

eTMF Lite

A focused trial master file for BE — 80% of the fields, 10% of the noise. Exports to your sponsor's eTMF.

03 · Intelligence

The BE research desk you'd otherwise have to build yourself.

Country trackers, regulator comparators, capacity benchmarks and deal-flow indicators. Subscription-based, licenced per seat or per team.

Market report

State of BE in Sub-Saharan Africa 2026

78 pages · 14 countries · site-level dataset

Regulatory guide

ANVISA vs. INVIMA vs. COFEPRIS: BE dossier differences

Comparative matrix + submission templates

Data brief

Global South BE capacity utilisation, Q1 2026

Quarterly · benchmark database access

Trust & verification

How a centre becomes Equiva Verified.

Verification is the whole point. The Equiva Verified badge is earned through a documented, inspected, continuously monitored process — not a self-declared logo. Standards are published, rubrics are public, and outcomes are transparent.

Standards we align to

ICH E6(R3) GCP
OECD GLP / WHO GCLP
WHO PQ bioequivalence guidance
ICH M10 bioanalytical validation
ALCOA+ data integrity
AMA reliance-ready dossier format

Designed to support AMA reliance pathways, REC mutual recognition and reduced duplication across NRAs.

01
Application & self-attestation
Centres submit accreditations, inspection history, capacity, bioanalytical method library and therapeutic experience through a structured intake.
02
Documentary & remote review
Equiva's regulatory desk reviews SOPs, QMS, GCP/GCLP evidence, method validation summaries and data-integrity controls against a published rubric.
03
On-site verification
Independent inspectors verify facilities, volunteer safety systems, bioanalytical lab, and eTMF against Equiva Verified standards — aligned with WHO PQ and AMA reliance expectations.
04
Continuous monitoring
Live study performance, deviations and inspection outcomes feed the badge. Verification is revoked or downgraded when standards slip — publicly and transparently.

The flywheel

Solve the coordination tax first. Layer tools and data on top.

Africa's pharmaceutical sovereignty moment is now. Local manufacturing is no longer optional — but every filing needs BE data. Equiva turns fragmented capacity into liquid, trusted supply.

01 · Supply

Sites & CROs

Free verified profile + SaaS tools (Volunteer Ops especially). Sites win RFQs they'd never have seen.

02 · Demand

Sponsors & manufacturers

Local & global generics houses post RFQs. Matched shortlist + Protocol Studio de-risks execution.

03 · Data

Intelligence layer

Anonymised transaction data becomes pricing benchmarks, NRA timelines, volunteer-pool signals.

04 · Moat

Regulatory goodwill

Verified network + clean execution data + reliance-ready dossiers. Hard to replicate, self-reinforcing.

Cost. 25–40% below India / Middle East benchmarks.

Relevance. Population-appropriate data for local reference products.

Trust. Data regulators can actually rely on under AMA reliance pathways.

04 · RFQ Matching

Sponsor posts. Sites bid. You award — in one workspace.

Replace the six-email-thread, three-spreadsheet, two-consultant sourcing process with a structured RFQ workflow that gets to a signed contract 4× faster.

Post your study

Molecule, design, subjects, timeline, target regulators. Public or private.

Matched shortlist in 72h

Equiva ranks eligible sites by capacity, experience and cost band.

Bid & award

Sites submit indicative quotes. You compare, message, and award. Equiva takes a success fee.

Founding cohort · Africa-first

We're seeding supply before we chase demand.

The first 40–50 verified sites across South Africa, Nigeria, Kenya, Egypt and Ghana get a fast-track Equiva Verified path — and set the quality bar the rest of the network is measured against.

For BE sites & CROs