Consultation

Audits & Inspections: Preparing laboratory and facilities for Regulatory and Quality Compliance audits/inspections
Speed to Markets: Microbiological controls in manufacturing and releasing quality products rapidly (Rapid Microbiological methods, PAT, Parametric releases) to the markets.
Design robustness assessments: Scientific risk model-based assessment of manufacturing facilities, formulations, Raw materials and packaging materials
Failure Investigations & resolutions: Marketed Product failure investigations, CAPA and risk assessment for Objectionable organisms
Training & coaching: Prepare teams and organization for Lab of the future/future generation of Microbiologists
Claims substantiation: Creating and supporting new Microbiological claims on the products (including claims for prebiotics, probiotics, preservative free)
Sterilization process controls: Microbiological Qualification of sterilization processes for Steam, Gamma,Ethylene oxide etc.
Laboratory processes & QMS: Establishing laboratory and Microbiological Quality Management Systems (QMS) for greenfield projects.
Data Integrity risk assessment & contamination control strategies: Implement Data Integrity risk assessment (DIRA) and contamination control strategies (CCS)

Protocol preparation for validation, Qualification, Microbiological studies etc.

Microbiological data and Report review

Report preparation from the raw data

Organize fit for purpose accredited CRO/Testing laboratories for specialized needs on Microbiology

Creating training modules and competency assessment plan

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