How we got started
Yusef Yacouba-Issa is the founder of PHARMALIGENT LLC which provides global Quality Assurance, Quality Control and Pharmaceutical consulting to develop programs and compliance processes that are fit for purpose. Dr. Yacouba-Issa has served as Quality representative during FDA, EMEA, TGA, PMDA, Health Canada, Genzyme and African Health authorities’ inspections and is considered a subject matter expert in GxP compliance activities for biologics, cell therapies, gene therapies and small molecules. Our expertise includes solid, liquid, topical, sterile, and other dosage forms, medical devices, and APIs in the US and abroad.
Why Choose Us?
Results Driven
We provide independent consulting that is proven, results-driven, and with excellent communication.
Knowledgeable
With the best minds in the pharmaceutical industry, we guarantee you will get outstanding results.
Experienced
We have over 15 years experience providing expert quality and compliance advice to FDA-regulated organizations.
Targeted
With our expert staff we analyze and prepare a custom plan with specific targets for your organization.
Our Expertise
Drug Development, Manufacturing, QA, QC, Quality Systems -Commercial drugs
Remediation of FDA commitments to 483s/Warning Letters
Site Validation Master Plan/ Cleaning Validation and Critical Utilities
Product Formulation, API Manufacturing
International regulatory audit response, Labelling & Packaging Finished Product
Change Controls / CAPA s /Deviations
IQ, OQ, PQ Validation Excutions
Product quality and trending analysis
QA/QC Laboratory operations support
Impact analysis and Risk Assessments
Batch record and SOP reviews
Root Cause Analysis; FMEA
Tech. Transfer from R&D to commercial
GMP Training; policies and procedures development and review; PAT/QbD
Medical device: GXP quality systems reviews and CAPA investigations / remediation; QMS audits; risk assessments
CSV Part 11 quality assurance audits
Supplier qualification programs
Annual product review preparation and evaluation and SOP reviews
Record retention cGMP requirements
Data integrity audits / application integrity policy procedure development
Bioavailability / Bioequivalence studies
Quality assurance support for critical utilities, equipment and facilities
Deviation investigations
Customer complaint remediation