Comprehensive CRO Services for Pharma, Biotech & Medical Devices
Indivirtus delivers end-to-end pharmaceutical consulting and CRO solutions—from toxicological risk assessments and regulatory compliance to medical device registration and GMP approvals. Our expertise spans computer system validation, equipment and HVAC calibration, NABL-accredited calibration (thermal, electro-technical, mechanical, pressure, mass & volume), and turnkey greenfield/brownfield projects. We also offer specialized training in GxP, cleaning validation, and quality systems—helping you accelerate approvals, ensure compliance, and scale with confidence.
0 +
PDE/OEL Reports as per
EMA | PIC/S | APIC | WHO
0 +
Mutagenic & Genotox Assessments
as per ICH, M7
Indivirtus Healthcare Services
- Toxicological Services
- Pharmacovigilance
- Greenfield/ Brownfield Projects
- CSV and Calibration
- Regulatory Affairs
- Formulation Development
Indivirtus Global CRO
- Bioavailability and Bioequivalence (BA/BE) Studies
- Clinical Trials
- Bio-Analytical
- Medical Writing
Indivirtus Strategic Solutions
- Pharmaceutical Product Technology package with Tech-Transfer support
- Export/ import of finished formulations
- Finding a suitable MAH across all regions
Indivirtus AB7 Scribing and RCM
- Medical scribing
- Revenue cycle management
- Medical transcription
Indivirtus Solutions
- Insurance Services
- Accounting Services
- Data Management Services
- International B.P.O.
Indivirtus Ecological Services
- Environmental Risk Assessment
- Ecotoxicology Studies
- Biodiversity Compliance
is a globally recognized Contract Research Organization (CRO) delivering comprehensive, science-driven solutions to pharmaceutical and healthcare companies worldwide. We specialize in Advanced Toxicological Risk Assessment (including critical impurities analysis, genotoxicity evaluations, ADE/PDE/OEL/OEB reports), Expert Regulatory Affairs, NABL-accredited Precision Calibration Services, Comprehensive Pharmacovigilance, and end-to-end Greenfield/Brownfield turnkey project consulting. Our mission is to help pharmaceutical and healthcare organizations achieve seamless regulatory compliance, ensure unwavering patient safety, and accelerate successful product development and market entry across 45+ countries globally.
Comprehensive Service Offerings
Toxicology & Cleaning Validation
Scientific exposure limits supporting cleaning validation, toxicological safety and global regulatory compliance.
Expert ADE, PDE, OEL, and OEB calculations for pharmaceutical cleaning validation that ensure patient safety and prevent cross-contamination in shared manufacturing facilities.
CRO Risk Assessment
Evidence-based impurity evaluation and toxicological risk assessments aligned with global standards.
Expert CRO services for comprehensive genotoxic impurity evaluation and medical device toxicological risk assessments. Ensuring regulatory compliance and patient safety.
Containment Validation
SMEPAC-driven containment verification for highly potent compounds and critical manufacturing environments.
Comprehensive verification of isolator performance to ensure complete operator and environmental safety when handling highly potent compounds.
Safety Documentation
Compliant MSDS/SDS development for pharmaceutical compounds and safe global handling.
Accurate and compliant preparation of Material Safety Data Sheets (MSDS) and Safety Data Sheets (SDS) for pharmaceutical compounds.
Pharmacovigilance
End-to-end PV support including signal detection, reporting systems and regulatory safety oversight.
Full-suite pharmacovigilance solutions from database setup to risk management plans for pharmaceutical safety monitoring.
Calibration Services
NABL-accredited calibration services maintaining precision, quality systems and audit readiness.
Keeping your critical instruments accurate and compliant with NABL-accredited calibration services you can trust.
Formulation Development
From pre-formulation research to commercial manufacturing, we help develop robust, effective, and scalable pharmaceutical formulations.
Accelerate your pharmaceutical product journey with expert formulation development, pre-formulation studies, process optimization, scale-up support, and regulatory guidance for global markets.
Analytical Development
From analytical method development to validation and regulatory support, we deliver reliable testing solutions for pharmaceutical quality and compliance.
Comprehensive analytical method development and validation services for pharmaceutical products, including stability-indicating methods, impurity profiling, cleaning validation support, and regulatory-compliant analytical documentation.
Regulatory Affairs
Technical and strategic support for dossiers, registrations, remediation and global approvals.
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.
Training & Capability
Expert-led capability building across GxP, quality systems, data integrity and regulatory readiness.
Hands‑on training on key topics like Cleaning Validation, GxP, Schedule M, WHO TRS, Data Integrity, Quality Culture, and QMS.
GMP Approval Support
Comprehensive support for facility approvals, gap assessments and international regulatory inspections.
Comprehensive CRO support for GMP approvals from global authorities like EU-GMP, USFDA, WHO-GMP, TGA, and more.
Greenfield / Brownfield
Single-window consulting for compliant pharma facilities from concept to qualification.
End-to-end project execution for new (Greenfield) and upgrade (Brownfield) pharmaceutical manufacturing facilities.
Validation Services
Comprehensive validation support for automated systems, instruments and critical environments.
Validation of laboratory systems, process automation, EMS, LIMS, HVAC and temperature mapping to support regulatory compliance.
Consumer Product Compliance
Regulatory assessments supporting food, cosmetic and consumer products market access.
Comprehensive GRAS evaluation services and CPSR preparation for FDA and EMA compliance in non-pharmaceutical industries, ensuring your products meet global safety standards.
Independent QA Oversight
QA governance for BA/BE, pre-clinical and clinical studies with regulator-ready compliance.
Independent QA oversight for BA/BE, pre-clinical, and clinical studies to ensure compliance, protect data integrity, and prepare for regulatory success.
Why Choose Us?
Regulatory Expertise
Deep understanding of USFDA, EMA, CDSCO regulations.
Certified Infrastructure
NABL certified labs, GMP-compliant facilities.
End-to-End Services
Complete solutions from preclinical to tech transfer.
Client-Centric Approach
Customized, transparent and responsive engagement.
Skilled Professionals
Qualified experts in science, QA, and compliance.
Data Integrity & Compliance
21 CFR Part 11, GLP/GMP practices ensured.
What our clients say
Join over 1,100+ satisfied clients worldwide
As per our experience in industry your service is one of the best, well trained people.
Mayur Bhoir
Industry Professional
Technically sound and professional services. In time delivery of reports at reasonable cost and complying global standards.
Vicky Shinde
Professional Services
Always timely support of documents with high quality assessment through knowledgeable SMEs including reasonable price.
Subba Rao
SME / Quality Assessment
Your commitment to delivering quality documents and exceptional service has been instrumental in our success. Their products consistently exceed our specifications.
Marwa Elsaka
Quality Documentation Client
This company helped us a lot with providing PDE reports of good quality. I am satisfied about their low pricing and promptness in resolving any issues.
Mahaling Pendkar (Atul)
PDE Quality Client
Our Global Footprint
Certifications & Accreditations
Few of Our Valued Clients
Have a Question? Let’s Talk
Scan QR to connect us on
WhatsApp
