SERVICES

Specialist support, shaped around your challenge.

BethAri offers five specialized service lines across medicines quality and regulation. Each service reflects delivered assignments for national regulators, regional bodies, or pharmaceutical manufacturers, combining rigorous technical assessment with practical implementation.

EMBEDDED CAPABILITY BUILDING

Training is integral to every engagement.

We train your teams on-site using your operational procedures, ensuring technical capability and compliance ownership remain within your organisation.

SERVICE 01

Quality Management Systems & ISO 9001

Core focus

QMS gap analysis, system design, ISO 9001:2015 roadmaps, and certification support.

Key outcomes

Working quality systems, audit-ready operations, ISO 9001 certification.

SERVICE 02

GxP Audits, Inspection Readiness & Laboratory Quality

Core focus

Site, supplier, vendor, and laboratory audits (GMP, GDP, GCP, GLP) and mock inspections.

Key outcomes

Identified compliance gaps, supplier qualification, audit readiness.

SERVICE 03

Regulatory Systems Strengthening & Sector Development

Core focus

Institutional evaluations, regional programme appraisals, and manufacturing sector studies.

Key outcomes

Actionable policy frameworks, sector mapping, programme sustainability.

SERVICE 04

Regulatory Affairs, Market Access & Product Registration

Core focus

Pathway strategy, CTD dossier review, Nigerian registration (NAFDAC/SON), and pharmacovigilance.

Key outcomes

Unlocked market access, compliant CTD dossiers, approved product licenses.

SERVICE 05

Digital Quality & AI-Enabled Regulatory Operations

Core focus

CMC workflow mapping, automation opportunity ranking, and AI implementation roadmaps.

Key outcomes

Eliminated submission backlogs, 90% error reduction, €2m+ recurring savings.

Tell us what you need to achieve