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As per our experience in industry your service is one of the best, well trained people.
Mayur Bhoir
Industry Professional
Indivirtus Healthcare Services · Est. 2018
Pharmaceutical CRO for toxicology, regulatory affairs and GMP compliance
We have prepared 14,500+ PDE/OEL reports and 3,500+ ICH M7 genotox assessments for clients in 64+ countries. Our team also handles regulatory filings, computer system validation and NABL-accredited calibration.
Not sure which service you need? Answer three questions and we will point you to it.
Which report do I need?
Step 1 of 3What are you working on?
Pick the closest match.
Certified & accredited
How we work
From first formulation to the pharmacy shelf, we cover every stage
Follow one molecule through its life. At each stage, these are the services our teams provide.
- Stage 01 / Development
A molecule becomes a product
Your formulation is designed, tested and made ready to scale, with analytical methods that will stand up to review later.
- Stage 02 / Safety
How much is safe?
Before a shared facility can make it, someone has to set the exposure limits. This is where most of our work starts.
- PDE/OEL reports
- 14,500+
- ICH M7 assessments
- 3,500+
- Stage 03 / Facility
A plant that passes on day one
New site or upgrade, the facility, its equipment and its computer systems all need to be qualified and calibrated.
- Stage 04 / Submission
The dossier goes in
We prepare and review what regulators read, for medicines and for medical devices.
- regulatory acceptance
- 100%
- toxicology dossiers
- 2,500+
- Stage 05 / Inspection
The inspector arrives
Gap assessments before the audit, independent QA for studies, and teams trained to answer the hard questions.
- Stage 06 / On the market
Patients start using it
Approval isn't the end. Safety signals still need to be collected, assessed and reported.
- Your product
Wherever yours is today, start there.
Most clients come to us for one report and stay for the next stage.
Trusted by 800+ pharmaceutical companies worldwide
- PDE/OEL reports (EMA · PIC/S · APIC · WHO)
- 14,500+
- Mutagenic & genotox assessments (ICH M7)
- 3,500+
- Toxicology dossiers
- 2,500+
- Countries served
- 64+
- On-time delivery
- 99.8%
15+ years of leadership
experience
experience
Why Indivirtus
A perfect blend of quality and economy
Indivirtus Healthcare Services is a global CRO serving 800+ clients across 64+ countries. One partner across toxicology, regulatory affairs, validation and project execution, so your submissions move faster with fewer hand-offs.
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Regulatory Expertise
Deep understanding of USFDA, EMA, CDSCO regulations.
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Certified Infrastructure
NABL certified labs, GMP-compliant facilities.
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End-to-End Services
Complete solutions from preclinical to tech transfer.
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Client-Centric Approach
Customized, transparent and responsive engagement.
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Skilled Professionals
Qualified experts in science, QA, and compliance.
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Data Integrity & Compliance
21 CFR Part 11, GLP/GMP practices ensured.
The Indivirtus group
Specialised companies, one ecosystem
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
Our Global Footprint
What our clients say
Join over 1,100+ satisfied clients worldwide
Trusted
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Technically sound and professional services. In time delivery of reports at reasonable cost and complying global standards.
Vicky Shinde
Professional Services
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Always timely support of documents with high quality assessment through knowledgeable SMEs including reasonable price.
Subba Rao
SME / Quality Assessment
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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
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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
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Get in touch
Have a regulatory deadline? Talk to an expert.
Tell us about your product and timeline, and our team will get back to you with a scoped plan.
- PDE/OEL, genotox and toxicology assessments
- Regulatory filings and GMP approvals
- Validation, calibration and turnkey projects
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