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.
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Which report do I need?
Step 1 of 3What are you working on?
Pick the closest match.
Certified & accredited
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%
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.
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 Backend Services
- Accounting Services
- Data Management Services
- International B.P.O.
Indivirtus Ecological Services
- Environmental Risk Assessment
- Ecotoxicology Studies
- Biodiversity Compliance
Headquartered in India. Trusted in 64 countries.
Orange names also have an international office: USA, Canada, UK, Egypt, UAE
What our clients say
“As per our experience in industry your service is one of the best, well trained people.”
“Technically sound and professional services. In time delivery of reports at reasonable cost and complying global standards.”
“Always timely support of documents with high quality assessment through knowledgeable SMEs including reasonable price.”
“I highly recommend them, I was impressed with their professionalism, pricing is fair and transparent - definitely value for money, efficiency and punctuality are their hallmarks.”
“We have taken various expert services from Indivirtus Healthcare which are recognised & well accepted by different regulatory agencies.”
“I am personally thankful for your continuous support virtuousness, honesty, transparency and ethics for pharma services, regulatory and compliance concept valuable suggestions.”
“In last 6 years company has gone leaps and bounds due to honesty, transparency and ethics, I congratulate the promoters and their hardworking staff.”
“A team mentored by Dr Upendra jain, willing to win the world by supporting in healthcare. Always optimist. Anyone will enjoy their journey with Indivirtus.”
“Their services were top-notch...Dr. Ashish is customer centric and transparent..and every time we are getting the reports on-time.. they are dealing the customer's issues quickly and professionally.”
“It is a pleasure working with the Indivirtus Healthcare team. Great staff and timely delivery of the services. All the best.”
“Expertise, professionalism, Knowledge, Promptness, Responsiveness, quality, Pricing, co-cooperativeness and behaviour make them ahead of many of the Pharma consultants.”
“We nice supportive. Highly knowledgeable staff. They help me to fill the CEP., very effectively... Very much satisfied with the service.”
“Indivirtus Healthcare Services Pvt. Ltd. provides top-notch, professional healthcare with a friendly and efficient staff. recommended!”
“I really appreciate about indivurtus employees and very professional and talented organisation, very helpful, we had an urgent situation and your lab did a great job helping us out.”
“It was a great pleasure when we met at ASIA PHARMA EXPO 24 at Dhaka, Bangladesh. We are sharing our knowledge and experiences. Hope it's grown up business.”
“We are satisfactory for the work done within the time line required. In future we look forward to work as well ... Dr. Ashish Nair was fully cooperating with us.”
“They provide cost effective consulting service and having good team of experts from different domains. A one stop solutions for all Pharma & Biotech industries.”
“This Indivirtus team is very sound in the knowledge database and helps technically to pharma industries and the timely delivery of study and support in case the query or concern raised by regulatory authorities.”
“The team is extremely experienced, knowledgeable, professional and helpful as we navigated our first of a number of clinical trials. Is evidence they are a standard, by which others should aspire.”
“Indivirtus has various capabilities to develop OEB/OEL/PDE reports as well as toxicological risk assessments for various pharmaceutical molecules. They are committed to time and develop reports in quick, scientific-oriented manner.”
“Indivirtus team is excellent to work with, very good technical knowledge and even great project management support by Priyanka, they are the preferred partners to work with for sure.”
“Best in class high quality services and solutions provider, Excellent technical expertise and resourceful people, Very transparent business model working with high level of integrity and ethics.”
“It is a very nice experience with the Indivirtus in doing the business. Indivirtus is very supportive and prompt in providing the services. Reports and information provided by indivirtus are reliable and authentic.”
“Indivirtus has been providing services in medical writing from past 5 years. They have excellent resources and sponsor friendly organization. I wish all the best in future endeavors.”
“Very professional approach for the toxicological evaluation support extended to our organization. It has been a wonderful experience interacting with the entire team.”
“The way their technical staff is handling any project is appreciable. I found them (specifically Priyanka mam) always ready to respond any kind of questions/ queries/ inquiries.”
“Indivirtus has good and knowledgeable group of experts who can support customers on time. Management is readily approachable to guide and solve any challenge.”
“Indivirtus is the name of quality with well-experienced staff, which is providing services to small firms and companies like us to survive against current nitrosamine, genotoxicity and toxicology studies.”
“Extremely happy with the professional service collaboration with Indivirtus Healthcare Services Pvt. Ltd. Their professional and proactive decision making process is very helpful for business execution.”
“Indivirtus has helped us by providing PDE reports. Prices are low, Dr. Upendra is very responsive and proactive in their services. Indivirtus has achieved the milestone in a very short span of time.”
“Your team providing timely support, your efforts have greatly contributed to the success of our projects. Your responsiveness, reliability, and attention to our expectations is truly grateful.”
“Our dealings with Indivirtus were very fruitful and team Indivirtus is well equipped to cater to your needs. Team members are friendly and possesses domain knowledge and expertise.”
“Excellent professional approach and backhand support from the company for any project outsourced. Maintains timelines and cost competitive also.”
“It’s an excellent place of an organisation for all technical solution under one umbrella. People are very much supportive at Indivirtus for different regulatory queries.”
“They are very much experienced and accurate in the toxicology assessment of materials. We set up a database for PDE for our products with the help of Indivirtus Healthcare Services.”
“I had a fantastic experience with Indivirtus. Their professionalism is unmatched, and their staff members are incredibly cooperative and helpful.”
“I am impressed by complete scientific and professional approach of Dr. Upendra and his devoted team. The customer/client-centric approach is a superb quality.”
“Indivirtus team provided service for Toxicological evaluation/Genotoxic to assess the impact. They delivered all the reports within our defined time line with required information.”
“Thank you for the exceptional service provided by indivirtus Healthcare. The professionalism and care exhibited by your team were truly commendable.”
“The management personnel are very co-operative. The PDE reports have been provided very promptly. Overall service and quality found very good.”
“Indivirtus Healthcare Services Pvt Ltd has a very good growth record since inception with a conscious focus on Pharmaceutical quality, Pharmacovigilance and regulatory aspects.”
“Reliable company! I have used some services from IVHS and I was extremely satisfied. Reliable team and prompt services.”
“I really appreciate Indivirtus team for timely support. They have a strong knowledge pool and are providing us very good toxicological services that meet regulatory expectations.”
“Indivirtus Healthcare demonstrated an in-depth knowledge of the pharmaceutical industry. Their guidance was not only insightful but also practical, providing actionable strategies.”
“Indivirtus plays a pivot role in pharma industry and provides multiple solutions. They respond to your queries swiftly and provide technical support wherever needed.”
“I am associated with Indivirtus for last five years for Genotoxicity, Nitrosamine risk assessment, PDE, ADE and OEL and my experience is excellent.”
“The team is qualified and highly motivated. The transparency and frequent interactions with the clients give Indivirtus an edge over others.”
“Expertise, professionalism, knowledge, and promptness. Very cooperative team. Fulfilled the request on top priority.”
“Indivirtus is having highly qualified and professional experts, helping you in each step during your any kind of customer support.”
“We have taken service for Toxicological evaluation of API molecules. Reports are detailed and have sufficient information as per regulatory requirements.”
“The collaboration for a clinical study was highly commendable. Their professionalism and punctuality in completing the study exceeded expectations.”
“I wanted to take a moment to express my appreciation for the high-quality data provided by Indivirtus team. The given data was accurate, reliable and in depth.”
“The quality of work delivered by your team consistently meets or exceeds expectations. From communication to project management, there is a strong sense of professionalism.”
“I received very positive and timely response from Indivirtus team regarding toxicology study literature for Cleaning Validation activity. Highly recommended.”
“This company helped us a lot with providing PDE reports of super high quality. Their team consists of highly qualified professionals.”
“It was really a great experience until now. While team is very co-operative with all expertise and most importantly Fastrack responsive at any time.”
“The seamless execution of tasks, adherence to protocols, and efficient communication throughout the study demonstrated a strong work ethic and focus on quality results.”
“Your commitment to delivering quality documents and exceptional service has been instrumental in our success. Their products consistently exceed our specifications.”
“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.”
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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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