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- GxP Services
GXP Services
- Training and Development on ICH Q7, 21 CFR Part 11, APIC, PIC/S guidelines.
- SOPs, SMF,VMP, Quality Manual and other GMP documents Preparation
- Customer and Regulatory Audit support with Compliance
- Vendor audit support for the KSM
- GAP analysis and Site Audit
- Facility qualification (URS,DQ,IQ,OQ and PQ with risk assessment)
- Product risk assessment as per ICH Q9
- Equipment/Instrument/Utility(Compressed Air, Nitrogen Plant) Qualifications
- Process and Cleaning Validation
- Purified Water and HVAC Validation
- Excelsheet Validation
- Software Services
Software Related Services compliance to GAMP 5, 21 CFR Part 11, EU Annex-11, PIC/S Guideline
- Computer System Validation
- Server and Networking Validation
- PLC Validation
- Electronic Document Management Software (Issuance, Archival and Storage)
- Material Management Software
- APQR Preparation Software
- Laboratory Management Software
- HR Management Software
- Training Management Software
- QMS Activity, Preventive Maintenance, Calibration, Stability Schedule Tracking Software
- Other required software can be developed based on customer requirement as well as customization will be done in existing software based on customer requirement
- Regulatory Services
Regulatory Services
- DMF Preparation, Review and Submission to Regulatory Authority like USFDA, EDQM,PMDA, ANVISA, CHINA, RUSSIA and other countries
- DMF Query Response
- eCTD Conversion of DMF
- US Agent Service for NDC and FEI number
- GDUFA site registration
- GDUFA fee submission and facility approval
- DUNS Number Services
- Characterization & Polymorphism with interpretation (IR,NMR,MASS, XRD,TGA)
- Nitrosamine Risk Assessment Report Preparation (Analytical method development and validation, Three batches analysis)
- Genotoxic Risk Assessment Report by QSAR or Equivalent Software
- Genotoxic (GTI) impurities carry over and purge study
- Elemental Risk Assessment Report as per ICH Q3D GUIDELINE PA/PH/CEP (16) 23, USP<232>&<233>/Ph. Eur. 2.2.57&2.2.58 (Analytical method development and validation, Three batches analysis)
- Analytical Services
Analytical Services
- Analytical Method Development and Validation for Non Pharmacopieal methods
- Analytical Method Validation for Pharamcopieal method (onsite or offsite)
- Forced degradation study as per ICH and ANVISA guideline
- Photostability studys per ICH and ANVISA guideline
- PSD, Microbial, Metal,HPLC,GC, IR,UV, TOC,BET related testing services
- Analytical intruments like HPLC,GC,IR, Auto Titrator maintenance services
- Impurity and product standards are available
- Training Programs
Training Programs
- GMP training as per ICH Q7
- Data Integrity training ALCOA++
- Analytical Method Validation
- Risk Assessment as per ICH Q9
- QMS system like Change Control, Deviation, Incident, Market Complaint, Returned Goods, OOS,OOT and CAPA
- Good Laboratory Practices
- Good Documentation Practices
- Good Engineering Practices
- Good Distribution Practices
- Vendor Qualification/Evaluation
- Audit Trail/Security Policy/Access Control
- Computer System Validation/Process/Cleaning Validation
- Training on Training
- Auditor Training
- Contact Us
- Home
- GxP Services
GXP Services
- Training and Development on ICH Q7, 21 CFR Part 11, APIC, PIC/S guidelines.
- SOPs, SMF,VMP, Quality Manual and other GMP documents Preparation
- Customer and Regulatory Audit support with Compliance
- Vendor audit support for the KSM
- GAP analysis and Site Audit
- Facility qualification (URS,DQ,IQ,OQ and PQ with risk assessment)
- Product risk assessment as per ICH Q9
- Equipment/Instrument/Utility(Compressed Air, Nitrogen Plant) Qualifications
- Process and Cleaning Validation
- Purified Water and HVAC Validation
- Excelsheet Validation
- Software Services
Software Related Services compliance to GAMP 5, 21 CFR Part 11, EU Annex-11, PIC/S Guideline
- Computer System Validation
- Server and Networking Validation
- PLC Validation
- Electronic Document Management Software (Issuance, Archival and Storage)
- Material Management Software
- APQR Preparation Software
- Laboratory Management Software
- HR Management Software
- Training Management Software
- QMS Activity, Preventive Maintenance, Calibration, Stability Schedule Tracking Software
- Other required software can be developed based on customer requirement as well as customization will be done in existing software based on customer requirement
- Regulatory Services
Regulatory Services
- DMF Preparation, Review and Submission to Regulatory Authority like USFDA, EDQM,PMDA, ANVISA, CHINA, RUSSIA and other countries
- DMF Query Response
- eCTD Conversion of DMF
- US Agent Service for NDC and FEI number
- GDUFA site registration
- GDUFA fee submission and facility approval
- DUNS Number Services
- Characterization & Polymorphism with interpretation (IR,NMR,MASS, XRD,TGA)
- Nitrosamine Risk Assessment Report Preparation (Analytical method development and validation, Three batches analysis)
- Genotoxic Risk Assessment Report by QSAR or Equivalent Software
- Genotoxic (GTI) impurities carry over and purge study
- Elemental Risk Assessment Report as per ICH Q3D GUIDELINE PA/PH/CEP (16) 23, USP<232>&<233>/Ph. Eur. 2.2.57&2.2.58 (Analytical method development and validation, Three batches analysis)
- Analytical Services
Analytical Services
- Analytical Method Development and Validation for Non Pharmacopieal methods
- Analytical Method Validation for Pharamcopieal method (onsite or offsite)
- Forced degradation study as per ICH and ANVISA guideline
- Photostability studys per ICH and ANVISA guideline
- PSD, Microbial, Metal,HPLC,GC, IR,UV, TOC,BET related testing services
- Analytical intruments like HPLC,GC,IR, Auto Titrator maintenance services
- Impurity and product standards are available
- Training Programs
Training Programs
- GMP training as per ICH Q7
- Data Integrity training ALCOA++
- Analytical Method Validation
- Risk Assessment as per ICH Q9
- QMS system like Change Control, Deviation, Incident, Market Complaint, Returned Goods, OOS,OOT and CAPA
- Good Laboratory Practices
- Good Documentation Practices
- Good Engineering Practices
- Good Distribution Practices
- Vendor Qualification/Evaluation
- Audit Trail/Security Policy/Access Control
- Computer System Validation/Process/Cleaning Validation
- Training on Training
- Auditor Training
- Contact Us
