Browse Our Comprehensive Service Offerings

01
🧪

ADE/PDE/OEL & OEB Calculation for Cleaning Validation

Expert ADE, PDE, OEL, and OEB calculations for pharmaceutical cleaning validation that ensure patient safety and prevent cross-contamination in shared manufacturing facilities.
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Service Scope

Key deliverables included

1
Comprehensive ADE/PDE/OEL Calculation Report
2
Scientific Justification with Detailed Methodology
3
Toxicological Monograph and Safety Summary
4
Risk Assessment Report for Cleaning Validation Protocols
5
Regulatory Compliance Support Documentation
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

02
🧬

Genotoxic Impurity & Medical Device Toxicology Assessment

Expert CRO services for comprehensive genotoxic impurity evaluation and medical device toxicological risk assessments. Ensuring regulatory compliance and patient safety.
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Service Scope

Key deliverables included

1
Comprehensive genotoxicity risk assessment report fully aligned with ICH Q3A/B/C/M7 guidelines
2
Evidence-based TTC impurity categorization and strategic qualification approach
3
Detailed Toxicological Risk Assessment (TRA) report for medical devices per ISO 10993 standards
4
Professional assessment of extractables and leachables (E&L) with regulatory interpretation
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

03
🛡️

Professional Isolator Containment Validation Services

Comprehensive verification of isolator performance to ensure complete operator and environmental safety when handling highly potent compounds.
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Service Scope

Key deliverables included

1
Comprehensive Containment Protocol with CPT & detailed sampling plan
2
Complete raw data and laboratory analysis reports
3
Professional Containment Validation Summary Report
4
Detailed excursion investigation & actionable recommendations
5
Official certificate of successful containment validation
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

04
📄

Material Safety Data Sheet (MSDS) / Safety Data Sheet (SDS) Preparation

Accurate and compliant preparation of Material Safety Data Sheets (MSDS) and Safety Data Sheets (SDS) for pharmaceutical compounds.
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Service Scope

Key deliverables included

1
GHS-Compliant SDS/MSDS (16-section format)
2
Chemical hazard classification and labeling
3
Toxicological and ecological data sheets
4
Transport and disposal information
5
Supporting references and data sources
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

05
💊

Pharmacovigilance & Drug Safety Monitoring Services

Full-suite pharmacovigilance solutions from database setup to risk management plans for pharmaceutical safety monitoring.
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Service Scope

Key deliverables included

1
Pharmacovigilance System Master File (PSMF)
2
Standard Operating Procedures (SOPs)
3
Setup and configuration of safety databases
4
ICSR processing reports
5
PSUR/PBRER/PADER submissions
6
Signal Detection Reports
7
Risk Management Plans
8
Literature surveillance logs and summaries
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

06
🛠️

NABL-Accredited Lab for Precision Instrument Calibration

Keeping your critical instruments accurate and compliant with NABL-accredited calibration services you can trust.
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Service Scope

Key deliverables included

1
Your Official NABL-Accredited Calibration Certificate
2
A Detailed, Traceable Calibration Report
3
Clear Records of All Deviations & Adjustments Made
4
A Handy Sticker and Recommendation for Your Next Calibration
5
Complete Documentation for Your Quality System (SOPs, Logs)
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

07
📄

Global Regulatory Compliance & Medical Device Registration

Navigate global markets with ease. We offer expert guidance on CTD/ACTD dossiers, medical device submissions, CEP/DMF filings, and act as your official regulatory representative.
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Service Scope

Key deliverables included

1
Ready-to-submit CTD/ACTD formatted dossiers (Modules 1-5)
2
Complete medical device applications for all classes (A-D)
3
CEP/DMF filing packages for key global agencies
4
Comprehensive clinical/non-clinical overviews and clear justifications for bioequivalence waivers
5
Professionally prepared regulatory response packages and remediation summaries
6
Official MAH/QP declarations and EU batch release certifications
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

08
🎓

Pharmaceutical Quality & Compliance Trainings

Hands‑on training on key topics like Cleaning Validation, GxP, Schedule M, WHO TRS, Data Integrity, Quality Culture, and QMS.
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Service Scope

Key deliverables included

1
Presentation slides & workbooks
2
Case‑study discussion materials
3
Training certificates
4
Post‑training checklist & action plan
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

09
🏭

GMP Approvals & Global Regulatory Readiness

Comprehensive CRO support for GMP approvals from global authorities like EU-GMP, USFDA, WHO-GMP, TGA, and more.
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Service Scope

Key deliverables included

1
Regulatory Readiness Assessment Report
2
Vendor Audit Checklist and Reports
3
CAPA and Risk Mitigation Plans
4
GMP Documentation Review Summary
5
Schedule M GAP Assessment Report
6
Audit Remediation Strategy Document
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

10
🏗️

Turnkey Greenfield & Brownfield Projects

End-to-end project execution for new (Greenfield) and upgrade (Brownfield) pharmaceutical manufacturing facilities.
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Service Scope

Key deliverables included

1
Concept-to-commissioning project plan
2
Facility layout and cleanroom design
3
Process flow diagrams (material, personnel, utility)
4
Equipment & utility qualification
5
Validation master plan (VMP)
6
Regulatory submission documentation (as needed)
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

11
✔️

CSV, Equipment & HVAC Validation Services

Validation of laboratory systems, process automation, EMS, LIMS, HVAC and temperature mapping to support regulatory compliance.
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Service Scope

Key deliverables included

1
Validation Master Plan (VMP)
2
User Requirement Specification (URS)
3
Risk Assessment & Qualification Protocols (IQ/OQ/PQ)
4
Traceable Test Scripts and Execution Records
5
Deviation/Incident Reports and CAPA
6
Final Validation Report & Summary
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

12
🧪

Food, Cosmetic & Consumer Safety

Comprehensive GRAS evaluation services and CPSR preparation for FDA and EMA compliance in non-pharmaceutical industries, ensuring your products meet global safety standards.
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Service Scope

Key deliverables included

1
GRAS Self-Affirmation or FDA Notification Dossier
2
Cosmetic Product Safety Report (CPSR) for EU/UK markets
3
Safety assessment documentation and expert evaluations
4
Regulatory compliance strategy and submission support
5
Post-approval regulatory maintenance guidance
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable

13
🛡️

Quality Assurance Services for BA/BE Studies & Related Fields

Independent QA oversight for BA/BE, pre-clinical, and clinical studies to ensure compliance, protect data integrity, and prepare for regulatory success.
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Service Scope

Key deliverables included

1
Detailed independent QA monitoring reports
2
Comprehensive CRO/vendor qualification audit reports
3
Pre-inspection readiness assessment findings
4
Thorough reviews of deviation and OOS/OOT investigations
5
Compliance and CAPA verification reports
Planning

Integrated

Execution

Field Ready

Outcome

Sustainable