QUALITY CONSULTING
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Park Avenue Group

Consultants with years of experience in Quality Assurance, Quality Control, Compliance and Regulatory. Extensive industry knowledge with domestic and international experience in Biotechnology, Pharmaceutical Sterile manufacturing, CAR-T, Nutraceuticals, Food, USDA and Contract manufacturing sites such as Pfizer, Eli Lilly, Sanofi , J&J and more. Areas of expertise also include Laboratory Operations, Inspection Readiness, Quality Systems, and Process Improvement. Skilled at conducting laboratory and facility audits, compliance training, batch assessments, playing a key role in the implementation of Quality Systems & ensuring completion of regulatory commitments.
Involved successfully in consent-decree, NDA, lifting of import alert, remediation of warning letters, batch assessments for release to the US market & Pre-Approval Inspection projects ensuring completion of commitments.


Why Park Avenue Group?
• FDA audit readiness.
• Batch certification and batch assessment. Onsite and remote.
• Deviations and investigations review. On site and remote.
• Documents review. On site and remote.
• Data integrity audit
• Technical writing on site and remote
• Laboratory Audit.
• Training and remediation.
•Deviation investigations and CAPA management on site and remote

•Quality Assurance and Quality Control Documents,Forms and Testing Procedures.
•Environmental Monitoring Protocol.

•Quality Assurance and Quality Control Documents,Forms and Testing Procedures.
•Environmental Monitoring Protocols
•Deviation investigations and CAPA management.
•Disinfectant efficacy testing protocol, media qualification protocol.


•Protocol review and execution oversight
•FDA audit preparedness.
•Disinfectant efficacy testing protocol, media qualification protocol.


•Qualifications, validation and/or co-validation of analytical methods involving different analytical Microbiology platforms .
•Preparation, editing, formatting and review of validation protocols, reports and associated Standard Operative Procedures (SOPs).

​Global Pharmaceuticals and Bio-pharma demand exceptional Quality Assurance and Quality Control 
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Consulting Industry leaders and Subject Matter expert

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Dr Loay AliKhan  CEO
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WHAT WILL YOU LEARN?

Unique & savvy solutions for the most complex Health care industry's

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See the Schedule
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Contact us for Support
USA 3477431280
UAE 971553130581
INDIA 7875398458

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