Embedded Files
List of Services
List of Services
N2N GXPS4U offers a full range of consultancy and advisory services in the biotech, pharmaceutical, and medical device industry. The team can augment your company for successful growth. The firm provides services to clients globally.
N2N GXPS4U offers a full range of consultancy and advisory services in the biotech, pharmaceutical, and medical device industry. The team can augment your company for successful growth. The firm provides services to clients globally.
Advisory
Advisory
General Regulatory StrategyÂ
General Regulatory StrategyÂ
General Quality Consulting
General Quality Consulting
Remediation
Remediation
Risk Management
Risk Management
Business Strategy and Due Diligence
Business Strategy and Due Diligence
Strategic Road Map - Business, Regulatory, Quality, Manufacutring, Clinical
Strategic Road Map - Business, Regulatory, Quality, Manufacutring, Clinical
Audits
Audits
GMP Audits - Contracted Suppliers, Manufacturers, Testing Facilities
GMP Audits - Contracted Suppliers, Manufacturers, Testing Facilities
GCP Audits - Clinical Site, Trial Master File, Clinical Research Organizations
GCP Audits - Clinical Site, Trial Master File, Clinical Research Organizations
GLP - Animal Facilities, Testing Facilities, General Laboratories
GLP - Animal Facilities, Testing Facilities, General Laboratories
GDP Audits - Distributors and Supply Chain
GDP Audits - Distributors and Supply Chain
Internal Audits - General Compliance
Internal Audits - General Compliance
Qualified Person Audits - European Union
Qualified Person Audits - European Union
Career & Leadership Coaching
Career & Leadership Coaching
Career Mapping
Career Mapping
Corporate Culture
Corporate Culture
Leadership Training
Leadership Training
Mentoring 1:1
Mentoring 1:1
Negotiation and Conflict Resolution
Negotiation and Conflict Resolution
Work Life Balance
Work Life Balance
Facility, Method, and Equipment
Facility, Method, and Equipment
Equipment Validation - IQ, OQ, PQ
Equipment Validation - IQ, OQ, PQ
Facility - Clean Room, Commissioning, Design
Facility - Clean Room, Commissioning, Design
Method Validation
Method Validation
Process Validation
Process Validation
Software Validation - CSV, CSA
Software Validation - CSV, CSA
Policies & Procedures
Policies & Procedures
Start-Up Packages - Basic Policies/SOPs to be compliant
Start-Up Packages - Basic Policies/SOPs to be compliant
Clinical SOP - Basic SOPs to quickly start up clinical trial
Clinical SOP - Basic SOPs to quickly start up clinical trial
Laboratory SOP - Basic SOPs for a safe and compliant laboratory
Laboratory SOP - Basic SOPs for a safe and compliant laboratory
Manufacturing SOP - Basic SOPs to quickly start up manufacturing controls
Manufacturing SOP - Basic SOPs to quickly start up manufacturing controls
Quality Assurance SOP - Basic SOPs to ensure product quality
Quality Assurance SOP - Basic SOPs to ensure product quality
Quality Control SOP - Basic SOPs to ensure product and process controls
Quality Control SOP - Basic SOPs to ensure product and process controls
Quality Management System SOP - Basic SOPs to ensure quality compliance
Quality Management System SOP - Basic SOPs to ensure quality compliance
Custom SOP - Client Specific SOPsÂ
Custom SOP - Client Specific SOPsÂ
Trainings & Seminars
Trainings & Seminars
Aseptic & Clean Room
Aseptic & Clean Room
General GXP - GCP, GLP, GMP, GDocP, GDP, GVP
General GXP - GCP, GLP, GMP, GDocP, GDP, GVP
Quality - GMP, GCP, GLP, QC, QA
Quality - GMP, GCP, GLP, QC, QA
Risk Management
Risk Management
Custom - Client Specific
Custom - Client Specific
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