Expertise – FDA Geek

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OUR SKILLS & EXPERTISE

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:

cGMP Compliance
Designing Quality Management Systems
Auditing and Gap Assessments (including Suppliers, Vendors, Third-Party Audits)
Process Improvements
Post Market Surveillance
Remediations
Data Integrity
Regulatory Compliance
Validation Services
Risk Management
Due Diligence
Project Based Staffing

Projects performed by FDA Geek

Pharmaceutical Projects: 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.

Drug-Device Combination Projects: Complaints, Trend Investigations, Design Quality Investigations

Medical Device Clients: Supplier Quality, Quality Engineering, Post Market Surveillance, Medical Device Reproting (MDR), EU MDR, CAPA, Change Management

Biotechnology: Deviation Investigations, Process Improvements, Supplier Quality

Vaccines: Data Integrity and Document Review for EUA and BLA submissions for COVID Vaccines.