Dr. Upendra K. Jain

Founder & CEO

With the ever-evolving changes in the national and international pharmaceutical industry, there is a need to adapt to the necessary measures for pharmacovigilance. The principal drivers for pharmacovigilance services are the enhanced global regulatory requirements, advancement in drug therapies, and improved focus on patient safety.

The regulatory agencies across the globe are setting higher standards to make drug makers more accountable for Adverse Drug Reactions (ADRs) and for reporting them. Further, the enhanced drug characteristics and interactions between the ingredients require more effective methods to assure patient safety. The growth of the pharmaceutical market with a simultaneous increase in the complexity of drug regimens and schedules, makes the implementation of pharmacovigilance services highly imperative.

This need has created a market for specialized service providers like Indivirtus Healthcare Services Pvt. Ltd., who have the expertise to assist pharmaceutical organizations in handling existing or potential risks associated with their products. Indivirtus is a relatively young company that was formed in 2018, but over a very short period, has become one of the market leaders in the field of pharmacovigilance and offers a wide range of services for monitoring the safety of drugs and managing associated risks for pharmaceutical companies worldwide.

“Our business has remained centrally concerned with pharmacovigilance functions to report, review, and monitor ADRs in accordance with regulatory specifications. We have established ourselves as a reliable partner for these important operations, in India as well as across the world,” says Dr Upendra K. Jain, Founder & CEO, Indivirtus.

Comprehensive Pharmacovigilance Services

Pharmacovigilance is one of the core businesses at Indivirtus. The primary services offered by the company include tracking of ADRs and submission of reports to appropriate authorities. This is a complex process that includes obtaining information about the adverse effects of patients from the patients, pharmacists, or other healthcare givers and identifying and classifying them. The information about these patients is stored in a database and handled in accordance with the applicable rules and regulations. Subsequently, the data is sent to the appropriate authorities, who may take appropriate measures as deemed necessary. This is a strict process to ensure that any inherent danger due to a drug is well understood and controlled.

Over the last few months, it has observed that the Indian drug rules and regulations have tightened owing to the general enhancement of control measures and safety in drug supervision worldwide. Indivirtus has been at the forefront of adopting these requirements, by improving systems and processes to meet the new set of standards.

This commitment to compliance and safety of the patient makes Indivirtus a valuable partner for pharmaceutical companies, striving to meet drug regulations and pharmaceutical requirements.

Toxicological Risk Assessment

Indivirtus in just short period of it's existence, has built a reputation as the primary toxicological risk assessment service provider of repute. Indivirtus is the only global service provider having a maximum of six certified (DABT/ERT) toxicologists. Toxicology reports are essential to ensure that drugs manufactured by pharmaceutical organizations are safe to use throughout their shelf life and do not have the potential to cause harm through contamination or drug-drug interactions.

Toxicological risk assessment is the process of assessing possible and potential risks of drug impurities and contaminations, especially in situations where drugs are manufactured in a shared facility.

Indivirtus has demonstrated its expertise in this field through the elaborate risk assessment documents reviewed and approved by DABT/ERT-certified toxicologists. In this way, it is possible to understand and prevent risks so that drugs remain safe for the patient.

Clinical Trials and Bioequivalence Studies

Another key service provided by Indivirtus is conducting Clinical trials and Bioequivalence studies.

Clinical trials are a critical step in determining the performance of the drug in question before it is marketed and consumed by the patient. The company performs these trials to obtain all necessary details about the effectiveness of the drug and its compliance with the relevant requirements.

Indivirtus has also specialization in conducting bioequivalence studies. These studies compare the effectiveness of the new drug against the reference or innovator drug to ascertain if the new product is comparable in terms of efficacy as well as safety. Through these studies, Indivirtus is able to assist pharmaceutical companies in proving that their products are bioequivalent and enable them to compete in newly targeted markets.

Engineering

Indivirtus Healthcare is an organization associated with Pharmaceutical, Veterinary, API, Biotech, Chemical, Medical devices, Hospital, Cosmetic, etc. for industrial facility designing, engineering consultancy, and turnkey project execution. With a team of experts and years of industrial experience, we provide a one-stop solution for all the requirements.

To cater variety of clients with different requirements we also provide solutions such as Feasibility study, Project execution and management, Plant installation-commissioning-validation-handover, Procurement assistance, etc.

We can deliver a tailor-made solution to match the client’s budget and quality requirements. Our products are precision-engineered for optimum and cost-effective performance. Our entire range of products is known for its impeccable quality, long life span, easy operation, and reliable performance.

Calibration

Our NABL-accredited lab (Certificate No- CC-3944) provides calibration services for Electro-Technical, Mechanical & Thermal disciplines as per international standards ISO/IEC 17025:2017. We offer competitive and cost-effective calibration solutions performed by well-qualified and trained engineers. Our laboratory offers both lab and on-site calibration services across various disciplines. In the thermal category, we provide services for temperature, relative humidity (RH), infrared, and more. Our mechanical calibration covers pressure, vacuum, speed, acoustic, weights, and balance. Additionally, we offer electro-technical calibration for AC/DC current, voltage, resistance, time, frequency, inductance, and insulation.

With the growing reliance on computer systems in the life sciences industry, computer system validation has become crucial. Indivirtus provides expert support to help clients validate systems ranging from simple PLC-based setups to complex enterprise-level applications like SAP, ERP, QMS, and LMS. Our services include automated manufacturing equipment validation (PLC, HMI, DCS, SCADA, IPC), validation of building management systems (BMS) and environment monitoring systems (EMS), and validation of various applications such as SAP HANA, ECC6, ERP, LIMS, LMS, DMS, and QMS, as well as in-house developed software. We also specialize in thermal validation, medical device validation, and laboratory software validation for systems like HPLC, GC, KF/Auto Titrator, LCMS, UV, and Polarimeter. Our expertise extends to Excel sheet development and validation (as per 21 CFR Part 11), GAP/GXP/21 CFR Part 11 assessments, CSV audits, and preparation and review of CSV documentation.

Innovation in Formulation Development

In recent years, Indivirtus has been diversifying its services and has started developing formulations and transferring the technology to potential clients/ organizations. These developments are done either at the company’s formulation development lab or at a partner’s development laboratory having the requisite equipment and the infrastructure to provide assistance in the development. Tests are conducted to determine that the new products are of required quality and safety with appropriate analytical methods before these can be transferred for commercial production.

This activity of confirming the quality parameters is very important when it comes to transferring new technologies from the laboratory to the production line. It provides an assurance to the client that the products being developed are compliant with the required standards set by the relevant authorities. The firm’s experience in this area helps pharmaceutical firms to launch new products at an earlier date and with minimal risk.

GMP Compliance for Regulatory Approvals

Indivirtus has been also providing services to the formulation industry by conducting third-party vendor audits of the API, excipient, and packing material manufacturers and suppliers. Indivirtus also conducts gap assessment audits with respect to the regulatory market requirements like the USFDA, EU-GMP, MHRA, ANVISA, and WHO as well as revised Schedule M. Indivirtus partners with its clients during these regulatory inspections and also provides complete support during the documentation of Corrective and Preventive Action (CAPA) proposals to the agencies.

Addressing Market Challenges

There could be multiple issues when pharma companies work with service providers in all the above mentioned or related fields. One of them could be the limited understanding of the company’s staff about the regulations and their interpretations. Variations in requirements are observed when dealing with multiple regions, and these variations are often seen as a challenge. However, Indivirtus has excelled in providing training on cGMP as well as other aspects of the Pharmaceutical Quality System (PQS) in a thoroughly professional manner to take the best course of action to avoid any non-compliance.

Another key issue is the need to balance cost containment while ensuring high-quality services. This is especially the case in a competitive market such as India where the profit margins are thin, and the cost of undertaking studies and managing compliance can be high. The company meets the challenge by providing all its services at an affordable cost to the clients without any compromise on quality, efficacy, and safety.

Leveraging Technological Advancements

Technological advancement in the services provided has been a gradual process, and Indivirtus continues to ensure that it is among the first to adopt new technologies. The firm is also in the process of strengthening its expertise in formulation development and technology transfer as these are core competencies for the development of new therapies. With a judicious approach to investing in newer technologies, Indivirtus strives to adapt to the future needs of the pharmaceutical industry while maintaining its value to its clients.

Expansion and Future Outlook

Starting as a single company, Indivirtus has grown rapidly and now it is a group of five companies. This growth is due to the company's performance, the far-reaching and innovative thought process of its founder, and the flexibility it has shown to adapt to the changing requirements of the pharmaceutical industry. The other member companies of Indivirtus, Indivirtus Strategic Solutions Pvt. Ltd., and Indivirtus Global CRO Pvt. Ltd., are also offering services to pharmaceutical clients across the globe.

Future developments of the firm include diversification of services. The company is especially interested in reviewing the biosimilar business and its demand globally/ It is also in the process of enhancing its position in formulation development and technology transfer segments.

Going forward, the mission of the company is to be a market leader in the context of the constantly changing requirements of the pharmaceutical market and make a positive contribution and impact to the improvement of patient relief.