INDIVIRTUS HEALTHCARE SERVICES P LTD 5020 Sec 38

INDIVIRTUS HEALTHCARE SERVICES (P) LTD. 5020, Sec 38 (W) Chandigarh | www. indivirtus. com

Indivirtus is a CRO which offers real time cost effective solutions to healthcare industry. We help the healthcare professionals and industry to maximize their efficiencies in its core competencies while helping them grow their business. This helps you to remain focused to your key areas while outsourcing the work of following key areas to experts at Indivirtus and synergize your operations. Indivirtus ensures total client satisfaction with the state of art facilities and fully secured migration framework for Medical writing, Pharmacovigilance, Health Economics, Scientific Publications and Medical Communications, Clinical trials and Bioequivalence studies. Therefore, we provide cost effective, customizable, user friendly, regulatory compliant services and completely auditable PV functionality.

VISION QUALITY MISSION POLICY To be among the top ten globally competent medical and health economics consultants capable of providing timely and accurate solutions with highest integrity to delight our customers, while also providing a challenging and growth-oriented environment to our team of experts having a great sense of pride and achievement. To facilitate our customers with quality outcomes and financial prudence by creating and nurturing a team of highly competent and innovative professionals, employing state of the art technology, by optimal utilization of human capital, with dedication to fulfil the needs of our valued customers and deliver complete customer satisfaction with precise finesse and excellence. Indivirtus is committed to excellence, to uphold the integrity of health economics and medical billing, to ensure world class quality and excellent customer service. We endeavour to achieve this niche position through constant innovation, up gradation and customer satisfaction while operating under an effective quality management system that fulfils the needs of our customers with cutting edge technology.

INDIVIRTUS HEALTHCARE SERVICES, WHY? § Helps to maximize your efficiencies in its core competencies and helping you grow your business. § Helps you to remain focused to your key areas while outsourcing the work on medical reporting and billing to the experts and synergize your operations. § Have the state of art facilities and fully secured migrations framework for Medical Scribe and Medical billing. § Ensures total client satisfaction. § Highly experienced and dedicated team for complete documentation using high end hardware and software to provide speedy solutions.

INDIVIRTUS HEALTHCARE SERVICES - BENEFITS 01 Provide real time reporting and data analytics 05 Improve business outcomes 02 Reduce costs of operations 06 Provide value added services 03 Delight the customer 07 Enhance productivity Reduce cost of hiring, burden of employees, their cost of training 08 Optimize resources 04

POTENTIAL BENEFITS OF OUTSOURCING SERVICES A well implemented service program can drive significant benefit for the outsourcing organization, including: • Converting fixed resource costs into variable, workload dependent charges, • Reducing the number of resources to recruit, manage, and/or train the staff, • Increased business model and capacity flexibility, • Improved efficiencies and Return on Investment (ROI) and • Well-documented cost benefits.

SERVICES OFFERED Environmental/Toxicological Services Regulatory Writing Scientific Publications and Medical Communications Pharmacovigilance Clinical Trials Health Economics and Outcomes Research Bioequivalence Studies

Environmental/Toxicological Services

PDE (Permitted Daily Exposure) or ADE (Acceptable Daily Exposure) • The ADE (FDA) or PDE (EMA) is a substance-specific dose that is unlikely to cause an adverse health event, if an individual is exposed to this dose or to a lower dose every day for a lifetime. • ADE/PDE are based on scientific evaluation of all available pharmacological and toxicological data, generally set exposureroute specific, in particular for the parenteral, the oral and the inhalation route.

Why are ADE/PDEs in Cleaning Process validation needed ? EMA Guideline on Shared Facilities (effective Jun. 2015) Acceptance Daily Exposure (ADE) or Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC) by scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data EU GMP Part 1 Chapter 3, and Chapter 5 (effective Mar. 2015) ü Applicable to human & veterinary pharma, drug substance & drug product, commercial & supplies FDA 21 CFR 211. 67 Equipment Cleaning and Maintenance (effective 2011) ü Implementation plan in industry according to risk prioritization (type and use of products, market, new products, facilities, …) should be scientifically justified. The assessment shall be documented in-writing. EU GMP Annex 15 (effective Oct. 2015)

Objective of ADE/PDE: • To ensure the safety of human patients and target animals exposed to residual active substances via medicinal products as well as consumers potentially exposed to residual active substances present in food of animal origin as a result of treatment of food producing animals with veterinary medicinal products in which residual active substances are present. • Aim is to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification.

Determining PDE/ADE: it’s a Hazard Assessment • Hazard identification through reviewing all relevant data • Identification of “critical effects” • Determination of the “no-observed-adverse-effects level (NOAEL)” of the findings that are considered to be critical effects • Use of several adjustment factors to account various uncertainties or gaps in the data.

Occupational Exposure Limit (OEL) • Acceptable airborne concentration for worker exposure • OELs for the protection of workers have been around at least since 1939 when the American Conference of Governmental Industrial Hygienists (ACGIH) published its inaugural acceptable workplace exposure limits (now known as threshold limit values, or TLVs). • Some sub-population of workers, due to individual susceptibility, may be adversely affected at concentration at or below the OEL. • Sometimes developed to protect even sensitive subgroups, e. g. , women of child bearing age, asthmatics. • Developed when a drug reaches significant manufacturing amounts or critical FDA stages

SKILLED TEAM A team of passionate and dedicated professionals at Indivirtus is equipped with following skills: Domain knowledge • Substantial knowledge of varied therapeutic regulatory/scientific guidelines and key statistical concepts. areas, Knowledge of audience • Understanding of the target audience, i. e. regulators, scientists, doctors, or pharma, life sciences and healthcare companies. Writing skills • Logical and succinct style of representing data supported with accurate interpretation.

SKILLED TEAM Data integrity • Maintaining accuracy, consistency and security of data – using stringent document management systems. Literature search • Using well-planned search strategy, appropriate keywords and a variety of sources when reviewing literature. An independent outlook • Performing critical content reviews, correctly interpreting results, identifying potential limitations and discussing unexpected findings.

SKILLED TEAM Clarity • Establishing clear objectives to organize ideas and embrace creativity. Keeping updated knowledge • At par with new relevant information, undergoing regular training programs to enhance their skills. Interpersonal skills • Well-honed verbal, non-verbal and listening skills for problem solving, negotiation and decision-making. Project management skills • Highly organized, proactive, respectful of metrics driven timelines and accepting accountability & responsibilities for quality.

Contact us: upendra@indivirtus. com veena@indivirtus. com +91 -9814133808 www. indivrtus. com