MMK BioPharma Consulting, LLC
Stage-Appropriate Quality Systems
GMP Quality Systems, QC operations, and supplier oversight.
EXPERIENCE THAT SPANS THE BIOPHARMA LIFECYCLE
MMK BioPharma Consulting is led by Mashooma Khalifa, a Quality professional with 14+ years of experience across pharmaceuticals, commercial vaccines, biologics, and cell and gene therapy.
Our practical support connects GMP Quality Systems, QC operations, deviation and CAPA management, OOS/OOT investigations, method validation and transfer, supplier lifecycle management, and CDMO oversight.
We work with emerging biotechnology companies, biologics and cell and gene therapy developers, CDMOs, and life sciences organizations to strengthen processes appropriate to their stage of development.
Consulting Services
Quality Systems Readiness Assessment
A focused review of Quality Systems, deviations, CAPA, documentation and vendor controls, with a prioritized remediation roadmap. Fixed-scope engagements: $5,000–$8,000.
Fractional Quality Systems Support
Defined monthly support for Quality workflows, documentation, investigations and operational priorities. Monthly engagements: $4,000–$7,500.
Supplier Quality & Vendor Oversight
Supplier qualification, vendor lifecycle processes, audit preparation and oversight documentation. Defined projects: $3,000–$6,000.
Scope, timelines and fees are agreed in a written proposal. Travel, on-site work and additional deliverables are scoped separately.
Education
2018
Northeastern University
MS Project Management
2012
Salem State University
BS Biology; Chemistry minor
Technical Expertise
Deviation & CAPA
QC Operations
Teamwork & Collaboration
Supplier Quality
Request a Consultation
Tell us about your organization, Quality priorities and timeline. Email: mkhalifa@mmk-bpc.com