Partnering with pharmaceutical and biotech organisations — from early clinical development through commercial manufacturing — to build inspection-ready, compliant quality systems.
Momentum Biopharma is a boutique consultancy specialising in GMP compliance, Quality Management Systems, and regulatory readiness for the pharmaceutical and biotech industries.
With a global footprint across the US, Europe, and Asia, we partner with organisations from early clinical development through commercial manufacturing to build and sustain compliant, efficient, and inspection-ready operations.
Our team combines hands-on technical expertise with strategic insight — helping clients establish robust quality systems, remediate deficiencies, and align with international regulatory expectations.
Whether you are a start-up biotech navigating your first FDA interaction or an established manufacturer addressing a Warning Letter, we bring the experience and rigour your situation demands.
Design, implement, and optimise GMP-compliant systems aligned with global regulatory expectations — focused on practicality and inspection readiness.
Build reliable, compliant supply networks — from supplier qualification through ongoing oversight, audit programmes, and CMO relationship management.
Operational quality support embedded within your team — ensuring seamless product release, batch record review, and day-to-day inspection readiness.
Expert computerised system validation and data integrity programmes across LIMS, BMS, MES, and ERP systems — GAMP 5, 21 CFR Part 11, EU Annex 11.
Sustainable compliance begins with empowered people. GMP training programmes that build lasting quality culture and competency at every level.
Leveraging our global network to support strategic sourcing, vendor selection, and supply chain resilience planning for pharma and biotech operations.
We partner with your team to build quality systems that are practical, sustainable, and built to last.
We work alongside your team as a true quality partner — hands-on, practical, and fully invested in your success.
We design quality systems that are fit for purpose and built for long-term performance, not just short-term fixes.
Sustainable quality starts with people. We focus on building competency, ownership, and a strong quality mindset at every level.
Senior-level attention on every project. No handoffs to junior staff — you get our best from start to finish.
Senior specialists ready to support compliance, system validation, and results-driven quality solutions.
Elham Barati is the Founder and Principal of Momentum Biopharma, bringing 15+ years of experience in FDA and EU GMP-regulated pharmaceutical and biotech environments. Rooted in a background in molecular and cell biology, Elham combines a strong scientific foundation with deep practical expertise in Pharmaceutical Quality Systems, inspection readiness, validation, and supplier quality. Throughout a career spanning roles at Genentech, Allergan, Novartis, and Seqens Pharmaceutical Solutions where Elham served as Site Quality Director, Elham has built and implemented phase-appropriate quality systems for GMP facilities from pre-clinical through commercial readiness, supporting clinical-stage and commercial manufacturing across the US, Europe, and Asia. A certified ISO 9001:2015 Lead Auditor, Elham brings a hands-on, pragmatic approach to compliance, building quality cultures that are both inspection-ready and built to last.
Vartan Hamparsoumian is a Quality Assurance and Data Integrity professional with deep expertise in Computerized System Validation (CSV) within GxP-regulated pharmaceutical and biopharmaceutical environments. Vartan lead the development and execution of site-wide data integrity policies, overseeing CSV projects and QA IT activities across key systems such as LIMS, BMS, and MES. With over ten years of experience spanning corporate, site, and consultancy roles, Vartan has led CSV remediation programs, legacy system assessments, and validation lifecycle management initiatives across multiple GMP facilities. His work ensures system compliance with GAMP 5, 21 CFR Part 11, and Eudralex Annex 11 requirements, supporting both FDA and European health authority inspections. He played a key role in driving global validation strategies, GxP risk assessments, and data integrity implementation across twelve manufacturing sites. Vartan holds a Master's degree in Pharmaceutical Engineering from Grenoble Alpes University and a Bachelor of Science in Biochemistry from Lyon Claude Bernard University. Fluent in French and English, he is recognized for his analytical approach, regulatory expertise, and ability to bridge QA and IT functions to sustain validated, compliant, and data-driven operations.
Whether you're preparing for an FDA inspection, building a QMS from scratch, or remediating a 483 finding — our team responds within one business day.