FDA Geek has hands-on experience in assisting clients with
Warning Letter Remediation, 483 Remediation, Gap Assessments, Auditing, Process Improvements, Reduction of Backlog of Complaints Investigations, Deviation Investigations, CAPAs, Data Integrity et.al.
Our expertise is listed below:
Deviation Investigations and Review, Product Complaints, Audits, Gap Assessments for Quality Systems, Post Market Surveillance, Data Integrity, Serialization, CAPA Review, Supplier Quality, Process Improvements and SOP Review.
Complaints, Trend Investigations, Design Quality Investigations.
Supplier Quality, Quality Engineering, Post Market Surveillance, Medical Device Reporting (MDR), EU MDR, CAPA, Change Management.
Deviation Investigations, Process Improvements, Supplier Quality.
Data Integrity and Document Review for EUA and BLA submissions for COVID Vaccines.