Principal Quality Consultant · Mahcom Consulting Services
Sepideh
J. Mahdavi.
24+ years across biologics, peptides, and advanced therapeutics — quietly running the quality systems that survive FDA, EMA, and QP inspections.
Warning Letter remediation, data integrity programs, GMP/GLP compliance, and CDMO/CRO oversight — delivered to biopharmaceutical clients worldwide.
Two decades inside the rooms where the regulators look closest — where data must hold under audit, and quality systems have to survive what comes next.
Mahcom Consulting · GMP Quality Practice
Engagement types
Four practices.
One discipline.
Every engagement is built on the same foundation: phase-appropriate quality systems, defensible documentation, and inspection-ready execution.
Warning Letter Remediation
Subject-matter expertise for FDA Warning Letter and 483 response. SME-level guidance through commitment closure, including aseptic manufacturing, analytical and microbial testing, and radiopharmaceutical QA/QC.
- •Commitment tracking and gap closure
- •QA coaching and on-site mentoring
- •Inspection-readiness verification
Data Integrity Programs
Gap assessments, mitigation, and program leadership aligned with FDA 21 CFR Parts 11, 210, 211, and 820, EU Annex 11, and ALCOA+. Including CRO laboratory reviews supporting bioequivalence and clinical studies.
- •Computerized system quality oversight
- •Audit trail, access, and change control review
- •CSV / SDLC documentation lifecycle
QC / QMS Compliance Enhancement
Compliance Enhancement Program (CEP) execution and QMS remediation across sample management, retention, stability, and analytical method lifecycle. Risk-based, phase-appropriate, and built to scale.
- •SOP revision and FDA/EMA alignment
- •Deviation / CAPA / change-control governance
- •QC organization design and leadership
CMC Quality Oversight
Quality representation for clinical-stage and commercial programs relying on global CDMOs/CMOs. Quality Agreements, specifications, analytical methods, master batch records, and release decision support.
- •Outsourced laboratory governance
- •Method validation, transfer, and lifecycle
- •IND / NDA / annual report CMC sections
Track record
Two decades.
A global client base.
Selected engagements
Where the
stakes are highest.
Recent and active consulting engagements across QA/QC, CMC, data integrity, Warning Letter remediation, and global GMP compliance. Client names are confidential; programs are described in anonymized form.
Active engagement
Quality Representation — CMC Documentation & QC/QA Oversight
Supporting two clinical-stage biopharmaceutical programs: one advancing oral small-molecule therapeutics and one developing an engineered biologic platform — both relying on global CDMOs and CMOs for development, manufacturing, and analytical execution.
- ›Comprehensive QA/QC oversight across CMC activities
- ›Phase-appropriate analytical method validation
- ›Quality Agreements, Specifications, Master Batch Records
- ›Batch record review and timely product release
Quality Representation — Product Complaint Review Support
Global pharmaceutical organization with a broad biologics and small-molecule portfolio. Complaint intake assessment, investigation review, and quality decision-making for FAR / escalation determinations.
- ›Quality complaint documentation and trending
- ›Investigation completeness assessment
- ›FAR/escalation decision support
- ›Field sample, retain, and trend evaluation
Selected past engagements
Compliance Enhancement Implementation — Gene Therapy
Site-wide CEP / QC remediation across sample management, retention, stability, and method-lifecycle processes. SOP revision and FDA/EMA alignment.
Data Integrity Review — Bioequivalence & Clinical Studies
Data integrity and quality review of CRO laboratory testing supporting bioequivalence and clinical study programs — analytical and cell-based assays.
Warning Letter Remediation — Radiopharmaceutical QA/QC
GMP radiopharmaceutical manufacturing and R&D facility. Analytical, diagnostic, and microbial testing oversight in Radiochemistry; QA mentoring for Warning Letter closure.
Data Integrity Support — Large-Scale Biologics
Comprehensive assessment of data accuracy, consistency, and completeness across multiple studies supporting FDA submissions for a major monoclonal-antibody manufacturer.
Warning Letter Remediation — Sterile Injectables & Biologics
High-throughput manufacturing site for US-approved sterile injectables and biologics. SME for aseptic manufacturing and analytical/microbial testing; QA coaching for FDA Warning Letter commitments.
Your engagement
Bring us the next one.
FDA 483 response. Warning Letter remediation. A data integrity gap your QA team flagged. A CDMO that needs hands-on quality oversight. Tell us what's at stake.
Industry lineage
Trained at the
top of the industry.
Two decades of progressive QC and QA leadership across some of the most rigorous biologics and peptide manufacturing organizations in the United States — before stepping into independent consulting.
Regulatory expertise
Frameworks
held in working memory.
About Sepideh
A scientist,
then a leader.
Sepideh began her career on the bench — performing QC release and stability testing for biologic products using HPLC, CE, LC/MS, ELISA, PCR, LAL, and sterility assays. Over two decades, she progressed through Senior Associate, QA Technical Manager, Senior Supervisor, Director, and Senior Director roles across Biogen, Genentech/Roche, Bachem Americas, and BioDuro.
At BioDuro she directed Quality Control operations supporting 35+ client programs across biologics and peptide therapeutics, built a high-performing QC organization of 20+ scientists and 4 managers, and hosted client and QP audits supporting commercial readiness. At Genentech she led technology transfer of a Phase III biologic assay and contributed to successful FDA inspection outcomes.
In 2023 she launched Mahcom Consulting Services to bring that depth — bench-up, leadership-tested, inspection-proven — directly to clinical-stage and commercial biopharmaceutical clients worldwide.
Graduate
MBA
Rady School of Management · UC San Diego
Graduate
M.S., Analytical Chemistry
Beheshti University · Tehran
Let's talk
Bring us your
hardest quality problem.
Every engagement starts with a conversation. Tell us about the program — the stage, the regulators, the CDMOs, the timeline. We'll respond within one business day.
Response time
Within one business day
Engagement size
3–18 month retainers
Location
San Diego · Global travel