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Contractual Closeout
Post Project Review
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User Requirements Specification (URS)
Design Qualification and Design Reviews
FAT (Factory Acceptance Tests) / SAT (Site Acceptance Test)
Installation Qualification
Operation Qualification (OQ)
Standard Operating Procedure
Performance Qualification
Process Validation/ Cleaning Validation
Risk Assessment
QMS Implementation
Developing QMS Policies and Procedures
Training and Awareness
Gap Analysis
Investigation Support
Root Cause Analysis
QMS Monitoring and Measurement
Technology Transfer and Product Development Support
Feasibility Assessment
Process Optimization
Regulatory Compliance
Documentation Preparation
Risk Assessment and Mitigation
Technology Transfer Execution
Scale-Up Assistance
Analytical Method Development
Quality Assurance and Compliance
Project Management
Regulatory Submissions
Submissions to Regulatory Authorities
Document Review and Elimination of Queries/Rejection
Drug Master File (DMF) Compilation
Response to Regulatory Queries
Regulatory Compliance and Gap Analysis
Post-Approval Changes Submissions
Guidance for ANDA and DMFs Preparation
Quality Assurance and Compliance
Lifecycle Management (LCM)
Investigational New Drug Applications (INDA) Submission
Review of Abbreviated New Drug Application (ANDA) Submissions
Review of Drug Master File (DMF) Submissions
Support for Remedial Action Plan (RAP) Post FDA Inspection
GMP Certification Services
Pre and Post Inspection Audits
Audit Compliance Reports
Facility Upgradation for GMP Compliance
Mock Audits
Due Diligence Audits
GAP Assessment Audit
Investigation Audit
Surveillance Audit
Follow-up Audit and CAPA Review
Audit
GMP Audits for API and Starting Materials
Supplier and Excipient Audits
GMP Audits for Third-Party Manufacturers
Packaging Material Audits
Third-Party Manufacturing Execution
QM System Audits
GDP and GLP Audits
Root Cause Audits
cGMP Consultants for Strategic Consulting
GAP Analysis and Mock Audits
Onsite cGMP Consultants
Audit Library
Upcoming Audit Schedule
Regulated Market Access
Product, Market & Regulatory Pathway Strategy
Regulatory Strategy for Emerging Markets
QMS Consulting
Engineering Solutions
Qualification and Validation
QMS Support
Regulatory Services
Contractor Collaboration
Training Solutions
Training
Good Manufacturing Practices (GMP) Training
Quality Control and Quality Assurance Training
Regulatory Compliance Training
Safety and Environmental Training
Current Good Clinical Practice (cGCP) Training
Data Integrity Training
Pharmacovigilance Training:
Process Validation Training
Computer System Validation Training
SOP and Documentation Training
Health and Hygiene Training
Product Specific Training
Leadership and Soft Skills Training
Audit
GMP Audits for API and Starting Materials
Supplier and Excipient Audits
GMP Audits for Third-Party Manufacturers
Packaging Material Audits
Third-Party Manufacturing Execution
QM System Audits
GDP and GLP Audits
Root Cause Audits
cGMP Consultants for Strategic Consulting
GAP Analysis and Mock Audits
Onsite cGMP Consultants
Audit Library
Upcoming Audit Schedule
QMS Consulting
Engineering Solutions
Qualification and Validation
QMS Support
Regulatory Services
Contractor Collaboration
Training Solutions
Engineering
Feasibility Studies
Site Selection
Facility Design and Layout
Design Risk Assessment
Detailed Engineering Design
Regulatory Compliance
Project Management
Technology and Equipment Selection
Commissioning and Qualification
Quality Assurance and Control
Training and Capacity Building
Contractual Closeout
Post Project Review
Supply Chain Management
Financial Analysis and Business Planning
Gallery
Faq's
Contact
Home
About Us
Services
Engineering
Feasibility Studies
Site Selection
Facility Design and Layout
Design Risk Assessment
Detailed Engineering Design
Regulatory Compliance
Project Management
Technology and Equipment Selection
Commissioning and Qualification
Quality Assurance and Control
Training and Capacity Building
Contractual Closeout
Post Project Review
Supply Chain Management
Financial Analysis and Business Planning
Qualification & Validation
User Requirements Specification (URS)
Design Qualification and Design Reviews
FAT (Factory Acceptance Tests) / SAT (Site Acceptance Test)
Installation Qualification
Operation Qualification (OQ)
Standard Operating Procedure
Performance Qualification
Process Validation/ Cleaning Validation
Risk Assessment
QMS Implementation
Developing QMS Policies and Procedures
Training and Awareness
Gap Analysis
Investigation Support
Root Cause Analysis
QMS Monitoring and Measurement
Technology Transfer and Product Development Support
Feasibility Assessment
Process Optimization
Regulatory Compliance
Documentation Preparation
Risk Assessment and Mitigation
Technology Transfer Execution
Scale-Up Assistance
Analytical Method Development
Quality Assurance and Compliance
Project Management
Regulatory Submissions
Submissions to Regulatory Authorities
Document Review and Elimination of Queries/Rejection
Drug Master File (DMF) Compilation
Response to Regulatory Queries
Regulatory Compliance and Gap Analysis
Post-Approval Changes Submissions
Guidance for ANDA and DMFs Preparation
Quality Assurance and Compliance
Lifecycle Management (LCM)
Investigational New Drug Applications (INDA) Submission
Review of Abbreviated New Drug Application (ANDA) Submissions
Review of Drug Master File (DMF) Submissions
Support for Remedial Action Plan (RAP) Post FDA Inspection
GMP Certification Services
Pre and Post Inspection Audits
Audit Compliance Reports
Facility Upgradation for GMP Compliance
Mock Audits
Due Diligence Audits
GAP Assessment Audit
Investigation Audit
Surveillance Audit
Follow-up Audit and CAPA Review
Audit
GMP Audits for API and Starting Materials
Supplier and Excipient Audits
GMP Audits for Third-Party Manufacturers
Packaging Material Audits
Third-Party Manufacturing Execution
QM System Audits
GDP and GLP Audits
Root Cause Audits
cGMP Consultants for Strategic Consulting
GAP Analysis and Mock Audits
Onsite cGMP Consultants
Audit Library
Upcoming Audit Schedule
Regulated Market Access
Product, Market & Regulatory Pathway Strategy
Regulatory Strategy for Emerging Markets
QMS Consulting
Engineering Solutions
Qualification and Validation
QMS Support
Regulatory Services
Contractor Collaboration
Training Solutions
Training
Good Manufacturing Practices (GMP) Training
Quality Control and Quality Assurance Training
Regulatory Compliance Training
Safety and Environmental Training
Current Good Clinical Practice (cGCP) Training
Data Integrity Training
Pharmacovigilance Training:
Process Validation Training
Computer System Validation Training
SOP and Documentation Training
Health and Hygiene Training
Product Specific Training
Leadership and Soft Skills Training
Audit
GMP Audits for API and Starting Materials
Supplier and Excipient Audits
GMP Audits for Third-Party Manufacturers
Packaging Material Audits
Third-Party Manufacturing Execution
QM System Audits
GDP and GLP Audits
Root Cause Audits
cGMP Consultants for Strategic Consulting
GAP Analysis and Mock Audits
Onsite cGMP Consultants
Audit Library
Upcoming Audit Schedule
QMS Consulting
Engineering Solutions
Qualification and Validation
QMS Support
Regulatory Services
Contractor Collaboration
Training Solutions
Engineering
Feasibility Studies
Site Selection
Facility Design and Layout
Design Risk Assessment
Detailed Engineering Design
Regulatory Compliance
Project Management
Technology and Equipment Selection
Commissioning and Qualification
Quality Assurance and Control
Training and Capacity Building
Contractual Closeout
Post Project Review
Supply Chain Management
Financial Analysis and Business Planning
Gallery
Faq's
Contact
Oral solid dosage form completed project
Medical Devices Completed Project
Large Volume parental ongoing project
Small Volume and large volume Ongoing Project
Training programs
