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 3

What 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.

  1. 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.

  2. 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+
  3. 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.

  4. 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+
  5. Stage 05 / Inspection

    The inspector arrives

    Gap assessments before the audit, independent QA for studies, and teams trained to answer the hard questions.

  6. Stage 06 / On the market

    Patients start using it

    Approval isn't the end. Safety signals still need to be collected, assessed and reported.

  7. 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%
Periodic-table tiles spelling Indivirtus above a laboratory display of its services: toxicology, regulatory and quality, validation and calibration, development and projects, and training
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.

  • 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.

Discover our story

Headquartered in India. Trusted in 64 countries.

Countries we serve All regions
AlgeriaArgentinaAustraliaBangladeshBhutanBulgariaCambodiaCanadaChinaColombiaCosta RicaEgyptEthiopiaFranceGabonGermanyGreeceHong KongIndiaIndonesiaIranIraqIrelandItalyJapanJordanKenyaKuwaitLatviaMalaysia
MoroccoMyanmarNamibiaNetherlandsNew ZealandNigeriaOmanPakistanPalestineParaguayPhilippinesRomaniaRussiaSaudi ArabiaSingaporeSouth AfricaSouth KoreaSpainSri LankaSwitzerlandTaiwanThailandTurkeyUAEUgandaUKUSAUzbekistanVietnam

Orange names also have an international office: USA, Canada, UK, Egypt, UAE

What our clients say

1,100+ positive responses from happy clients
“As per our experience in industry your service is one of the best, well trained people.”
Mayur Bhoir
“Technically sound and professional services. In time delivery of reports at reasonable cost and complying global standards.”
Vicky Shinde
“Always timely support of documents with high quality assessment through knowledgeable SMEs including reasonable price.”
Subba Rao
“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.”
Hend Mamdouh
“We have taken various expert services from Indivirtus Healthcare which are recognised & well accepted by different regulatory agencies.”
Kashyap Nagariya
“I am personally thankful for your continuous support virtuousness, honesty, transparency and ethics for pharma services, regulatory and compliance concept valuable suggestions.”
QA Head
“In last 6 years company has gone leaps and bounds due to honesty, transparency and ethics, I congratulate the promoters and their hardworking staff.”
Manoj Agrawal
“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.”
Partha Mondal
“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.”
Meera Ns
“It is a pleasure working with the Indivirtus Healthcare team. Great staff and timely delivery of the services. All the best.”
Romen Singh
“Expertise, professionalism, Knowledge, Promptness, Responsiveness, quality, Pricing, co-cooperativeness and behaviour make them ahead of many of the Pharma consultants.”
Shrenik Shah
“We nice supportive. Highly knowledgeable staff. They help me to fill the CEP., very effectively... Very much satisfied with the service.”
Chetan Raiyani
“Indivirtus Healthcare Services Pvt. Ltd. provides top-notch, professional healthcare with a friendly and efficient staff. recommended!”
Gulshan Kumar
“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.”
Chetan Prajapati
“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.”
Chemkey Info
“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.”
Abdul Sajid
“They provide cost effective consulting service and having good team of experts from different domains. A one stop solutions for all Pharma & Biotech industries.”
Sudeep Kumar Patra
“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.”
Mahesh Utage
“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.”
Kungfu Bob
“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.”
Maged Fawzy
“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.”
Prabhakar Lahare
“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.”
Jatin Savani
“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.”
Dr. Kishor Kadam
“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.”
Ghouse Mohiddin
“Very professional approach for the toxicological evaluation support extended to our organization. It has been a wonderful experience interacting with the entire team.”
Rajen Mahajn
“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.”
Anupsinh Gadhavi
“Indivirtus has good and knowledgeable group of experts who can support customers on time. Management is readily approachable to guide and solve any challenge.”
Dr. Ravindra Vedantham
“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.”
Shoukatalli Naikwade
“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.”
S Borah
“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.”
Shrikant P
“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.”
Dattatray Govare
“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.”
Virag Divanji
“Excellent professional approach and backhand support from the company for any project outsourced. Maintains timelines and cost competitive also.”
VGS Sharma
“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.”
Rakesh Parmar
“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.”
Shaun Bency
“I had a fantastic experience with Indivirtus. Their professionalism is unmatched, and their staff members are incredibly cooperative and helpful.”
Bornila Mehjabin
“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.”
Pratibha Omray
“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.”
Sudhir Kumbhar
“Thank you for the exceptional service provided by indivirtus Healthcare. The professionalism and care exhibited by your team were truly commendable.”
Sakshi Thakur
“The management personnel are very co-operative. The PDE reports have been provided very promptly. Overall service and quality found very good.”
Parth Mehta
“Indivirtus Healthcare Services Pvt Ltd has a very good growth record since inception with a conscious focus on Pharmaceutical quality, Pharmacovigilance and regulatory aspects.”
Salil Saksena
“Reliable company! I have used some services from IVHS and I was extremely satisfied. Reliable team and prompt services.”
Ashish Vyas
“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.”
Nagarajan Balasubramanian
“Indivirtus Healthcare demonstrated an in-depth knowledge of the pharmaceutical industry. Their guidance was not only insightful but also practical, providing actionable strategies.”
Rohit
“Indivirtus plays a pivot role in pharma industry and provides multiple solutions. They respond to your queries swiftly and provide technical support wherever needed.”
Anish Rove
“I am associated with Indivirtus for last five years for Genotoxicity, Nitrosamine risk assessment, PDE, ADE and OEL and my experience is excellent.”
Ravindra Palkar
“The team is qualified and highly motivated. The transparency and frequent interactions with the clients give Indivirtus an edge over others.”
Ashok Omray
“Expertise, professionalism, knowledge, and promptness. Very cooperative team. Fulfilled the request on top priority.”
Manoj Jadhav
“Indivirtus is having highly qualified and professional experts, helping you in each step during your any kind of customer support.”
Neeraj Vishwakarma
“We have taken service for Toxicological evaluation of API molecules. Reports are detailed and have sufficient information as per regulatory requirements.”
Deepak Khandelwal
“The collaboration for a clinical study was highly commendable. Their professionalism and punctuality in completing the study exceeded expectations.”
Rajeev Pandit
“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.”
Deepak Pallewar
“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.”
Dr. Vats
“I received very positive and timely response from Indivirtus team regarding toxicology study literature for Cleaning Validation activity. Highly recommended.”
Ganesh Patil
“This company helped us a lot with providing PDE reports of super high quality. Their team consists of highly qualified professionals.”
Диана Назарова
“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.”
Swapnil Pawar
“The seamless execution of tasks, adherence to protocols, and efficient communication throughout the study demonstrated a strong work ethic and focus on quality results.”
Dr. R. Valavan
“Your commitment to delivering quality documents and exceptional service has been instrumental in our success. Their products consistently exceed our specifications.”
Marwa Elsaka
“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)
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

Have a Question? Let’s Talk

Fill out the form below and we'll reply within 12 hours.