Consulting Services: GxP auditing, ISO auditing, inspection readiness, small molecules and biologics, sterile and non-sterile manufacturing, quality system development and improvement, SOP development, gap assessment, risk assessment, remediation from Agency inspections, batch record review, vendor qualification, CMC, CTD Module 3 related document review, drafting Site Master File, compiling validation protocols and reports, summarizing process verification reports, deviation investigation, root cause analysis, CAPA execution, change control process, method transfer and validation, analytical and bioanalytical testing,  data review, handling complaints and recalls, Annual Product Review, drafting quality agreement, Lot Release Protocol population, training, drug and medical device establishment license activities, cannabis license application

Analytical & bioanalytical skills: HPLC, UV/VIS, GC, SDS PAGE, ELISA, PCR, FTIR/IR, titration, TOC, GPC, cell culture, DNA Assay, p-NPB test, fluorometer, XPS, conductivity, osmolality

Computer skills and data management systems: Windows, Word, Excel, PowerPoint, TrackWise, SAP, LIMS, NuGenesis, Phenix, Procal, Ennov, AX, Chemstation, Empower, etc.

Innova Medipharm Inc.

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Innova Medipharm Inc.

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Teams

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