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Indivirtus Healthcare Services Pvt Ltd

Indivirtus Healthcare Services Pvt Ltd is listed as a mid sized business research supplier in the Scientist.com network, with 1 site in 1 country.

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Type of company: Mid sized business

Chemical and Compound Analysis

Dissolution Profiling Measure release of API from formulation (tablet or capsules) under GMP guidelines.

Chemical and Compound Testing

Occupational Exposure Limits (OEL) Reports Develop and determine the Occupational Exposure Limit of a substance or compound. The OEL is the value which indicates the level of exposure to be safe in the workplace.

Chemistry, Manufacturing and Controls (CMC)

Analytical Development and Validation Request services related to Analytical Development and Validation
API manufacturing process development, tech transfer and validation API manufacturing process development, tech transfer and validation
API/ Excipients Compatibility Studies Delineate real and possible interactions between potential formulation excipients and the API as an important risk reduction exercise early in formulation development.
Chemistry, Manufacturing and Controls (CMC) Request Chemistry, Manufacturing and Controls services
Drug Formulation Combine substances including the active drug into a final product with the desired metabolic and therapeutic properties.

Clinical Consulting

Clinical Development Planning Complex document that entails the entire clinical research strategy of a drug, describing the clinical studies that will be carried out for a pharmaceutical entity.
Clinical Protocol Design & Development Creation of clinical protocol document which details how a clinical trial is designed, relating to to the methodology, hypothesis, and operation of clinical trial to ensure the safety of the patients is...
Clinical Trial Recruitment Recruitment, enrollment and retention of patients for clinical trials.
IND Writing Consulting Consulting for an Investigational New Drug Application
Regulatory Compliance & Documentation Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.
Regulatory Consulting Ensure that each product or device complies with all FDA rules and regulations.

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Clinical Trials

Bioequivalence Studies Assess the expected biological equivalence of two proprietary preparations of a drug.
Case Report Monitoring & Auditing Ensure the adequate collection and traceability of clinical data in preparation for review by the FDA.
Clinical Trial Design Develop study-related protocols, case report forms (CRFs) and database tools for records management.
Clinical Trial Risk Management Plan that maintains treatment quality throughout lifecycle and improve decision making.
eCOA - Electronic Clinical Outcomes Assessments Use smartphones, computers and tablets to allow patients to directly report health outcomes.
Patient Recruitment Recruit and retain patients for clinical trials.

Show all 12 in Clinical Trials 6 more

Phase 1-3 Studies Design phase 1-3 studies that seek to identify if a drug is safe, effective, and more efficient than other available treatments on the market.
Post-Marketing (Phase 4) Studies Conduct phase 4 studies for confirming unrecognized safety issues, investigating possible hazards or establishing the expected safety profile of a veterinary medicinal product under market conditions.
Prospective Explorative Studies Conduct a prospective exploratory study to assess the safety and efficacy of a test drug during clinical trials.
Regulatory Affairs Consulting Receive assistance ensuring compliance with regulatory requirements.
Site Monitoring Maintain oversight over participant's health during a clinical trial.
Site Selection Select clinical trial sites with clinicians who recruit, enroll, treat and evaluate trial patients.

Data Science/Bioinformatics

Discovery Data Management A process that includes acquiring, validating, storing, protecting, and processing required data to ensure the accessibility, reliability, and timeliness of the data for its users.

Discovery Chemistry

In Silico Metabolite Predictions Conduct in silico assessment of metabolite pharmacokinetic properties and potential exposure effects.
Leachable and extractable testing Leachable and extractable testing
QSAR Analysis Develop quantitative structure–activity relationship models for drug design.

General in vivo Toxicology

Repeat Dose Toxicity Study - Dog / Canine Conduct a repeat dose study in dogs to determine the toxicity and toxicokinetic behavior of your compound.
Repeat Dose Toxicity Study - Other Species Conduct a repeat dose study in other species to determine the toxicity and toxicokinetic behavior of your compound.

HEOR

Cost Benefit Analysis Economic evaluation in which costs and benefits (outcomes) are expressed in monetary units, to determine if the benefits of an intervention outweigh the costs.
Cost Effectiveness Analysis Compare alternative treatments that lead to similar health outcomes.
Health Economics and Outcomes Research (HEOR) Evaluate data collected during drug development to maximize the value of a therapeutic product.
Patient Reported Outcomes (PRO) Assessment of health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician.
Systematic Literature Review Summarizes the results of research (that meet pre-defined eligibility criteria for inclusion) and provides a high level of evidence on the outcomes assessed.

Human Biological Samples

HBS: Human Biological Samples Request human biosamples including tissues, blood, serum, bone marrow, tissue microarrays, etc.

In Vitro ADME

Permitted Daily Exposure (PDE) Evaluate the health based exposure limits or permitted daily exposure of different medicinal products in shared facilities during manufacturing.

In Vitro Toxicology

Genotoxicity Evaluate potential of a compound to cause mutations and chromosomal aberations

In Vivo Pharmacokinetics

Pharmacokinetic (PK) Screening - Other Species Run pharmacokinetic studies in large animals that measure a drug's absorption, distribution, metabolism and excretion.
Pharmacokinetic (PK) Screening - Rat Run pharmacokinetic studies in rats that measure a drug's absorption, distribution, metabolism and excretion.

Management Optimization & Development Strategies

OECD Regulatory Development Consultation in safety testing, chemical notification and registry within OECD.

Medical Communications

Medical Writing and Editing/Manuscript Development Communicate scientific, technical and health-related information to a range of audiences.
Protocol and Study Reports Write protocol and study reports, specifically relating to the drafting, writing, and editing of Clinical Safety Reports.

Medical/Commercial

Life Cycle Assessment (LCA) Analyze the lifecycles of the products and services with regard to their environmental impacts.

REACH Services

Hazard, Exposure and Risk Assessment Evaluate the known hazard of a test compound in conjunction with the expected quantity and frequency of exposure.
In Vitro REACH Services Perform skin or eye irriation tests, sensitivily and geneotoxicity tests
OECD 402: Acute Dermal Toxicity This method provides information on health hazard likely to arise from short-term exposure to a test chemical by dermal route.
OECD 403: Acute Inhalation Toxicity This method provides information on health hazard likely to arise from short-term exposure to a test article (gas, vapour or aerosol/particulate test article) by inhalation.
OECD 404: Acute Dermal Irritation/Corrosion This method provides information on health hazard likely to arise from exposure to liquid or solid test substance by dermal application.
OECD 405: Acute Eye Irritation/Corrosion This method provides information on health hazard likely to arise from exposure to test substance (liquids, solids and aerosols) by application on the eye.

Show all 24 in REACH Services 18 more

OECD 406: Skin Sensitisation This method provides information on health hazard likely to arise from exposure to test substance via intradermical injection and/or epidermical application.
OECD 407: Repeated Dose 28-day Oral Toxicity Study in Rodents This method provides information on health hazard likely to arise from exposure to test substance via oral administration.
OECD 408: Repeated Dose 90-Day Oral Toxicity Study in Rodents This method provides information on health hazard likely to arise from exposure to test substance via oral administration.
OECD 410: Repeated Dose Dermal Toxicity: 21/28-day Study This study relates to the analysis, via dermal application, of the health hazard of solid or liquid test substance.
OECD 411: Subchronic Dermal Toxicity: 90-day Study This study relates to the analysis, via dermal application, of the health hazards of solid or liquid test substance.
OECD 414: Prenatal Developmental Toxicity Study This Test Guideline for developmental toxicity testing is designed to provide general information concerning the effects of prenatal exposure on the pregnant test animal and on the developing organism.
OECD 420: Acute Oral Toxicity - Fixed Dose Procedure A principle of the method is that in the main study only moderately toxic doses are used, and the administration of doses that are expected to be lethal should be avoided. This Guideline is intended primarily for use...
OECD 421: Reproduction/Developmental Toxicity Screening Test The test substance is administered in graduated doses to several groups of males and females.
OECD 436: Acute Inhalation Toxicity – Acute Toxic Class Method The method described by this Test Guideline provides information that allows hazard assessment for short-term exposure to a test article by inhalation, and allows the substance to be classified according...
OECD 451: Carcinogenicity Studies The objective of a long-term carcinogenicity study is to observe test animals for a major portion of their life span for the development of neoplastic lesions during or after exposure to various doses of a test...
OECD 452: Chronic Toxicity Studies Evaluate the direct and indirect impact of prolonged and repeated toxin exposure to test organisms.
OECD 471: Bacterial Reverse Mutation Test (Ames) Measure the mutagenic potential of test compounds.
OECD 473: In Vitro Mammalian Chromosomal Aberration Test Assess the ability of the test substance to cause structural chromosomal aberrations in cultured mammalian cells.
OECD 474: Mammalian Erythrocyte Micronucleus Test The mammalian in vivo micronucleus test is used for the detection of damage induced by the test substance to the chromosomes or the mitotic apparatus of erythroblasts, by analysis of erythrocytes as sampled in bone...
OECD 475: Mammalian Bone Marrow Chromosomal Aberration Test The mammalian in vivo chromosome aberration test is used for the detection of structural chromosome aberrations induced by test compounds in bone marrow cells of animals, usually rodents (rats, mice and Chinese...
OECD 476: In Vitro Mammalian Cell Gene Mutation Test (Mouse Lymphoma Assay) Determine if a compound is mutagenic by using cultured mammalian cells.
OECD 486: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo The purpose of the unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo is to identify substances that induce DNA repair after excision and removal of a stretch of DNA containing a region of damage...
OECD 487: In Vitro Mammalian Cell Micronucleus Test Assess whether a test substance induces chromosomal changes in cultured cells.

Real World Evidence & Data

Meta-Analysis Use quantitative statistical approaches to pool results across multiple studies to improve power or resolve uncertainty; may be used in conjunction with a systematic review.
Non-Comparative Study Assess an intervention using a single arm study design (without a control or comparator group).
Pragmatic Clinical Trial Randomized trial comparing two or more treatments in a real world setting. The trial possesses minimal exclusion criteria and closely follows the procedures of the clinical practice in order to mirror clinical care...
Real World Evidence (RWE) Studies Studies (prospective or retrospective) utilizing data obtained from "real world settings" , and is outside the tight controls of a clinical trial design.
Real-World Data Acquire real-world data from patients' electronic medical records including clinical information generated during the course of healthcare.
Real-World Evidence Acquire clinical data from patients' medical records to analyze trends and the frequency of occurrence of different medical conditions.

Show all 9 in Real World Evidence & Data 3 more

RWD - Electronic Medical Record (EMR) Digital version of a patient's medical or health chart containing demographic, clinical, medical, and other treatment information.
RWE/HEOR/Market Access Safety Surveillance Monitor safety of treatment and determine methods to identify adverse events early
Secondary Real World Evidence Analyze clinical trial data.

Regulatory Affairs

Patient Risk Management Identify, contain, and manage risks related to patient safety.
Period Benefit Risk Evaluation Report (PBRER) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
Periodic Safety Update Report (PSUR) Preparation of safety reports to report adverse events that occurred during a specified time period. Evaluate if safety profile of treatment has changed since last report
Post Authorization Efficacy Study (PAES) Answer uncertainties in efficacy of treatment, and improve understanding of treatment and the benefit-risk profile. These studies are specifically asked for by European Medicines Agency (EMA) to continually grant...
Post Authorization Safety Study (PASS) Evaluate the safety, benefit-risk profile, and risk management of a treatment. These studies are specifically asked for by European Medicines Agency (EMA) and they can be mandatory or voluntary.
Post-authorization Safety Studies Research efforts conducted after a drug has been approved for market to monitor its safety profile in the general population. These studies aim to identify, characterize, or quantify potential adverse effects...

Show all 8 in Regulatory Affairs 2 more

Risk Evaluation & Mitigation Strategy (REMS) Evidence required by FDA to support the benefit of treatment outweighs the risks. Purpose of REMS is to prevent, monitor, and manage serious risk by informing, educating, and reinforcing actions to reduce frequency...
Safety Signals Early indication that a new or unknown adverse event occurred that may be caused by treatment and investigation is needed to determine a causal relationship. Can be investigated through spontaneous reports, studies...

Testing Services

Bacterial Reverse Mutation Assay Test whether a cosmetic product or ingredient causes DNA mutations in bacteria.
Elevated Temperature Stability Determine the stability of a product at elevated temperature.
OECD 439: Skin Irritation Test (SIT) Reconstructed Human Epidermis Test (RhE) Method - An in vitro testing method designed to identify chemicals and/or mixtures capable of inducing moderate skin irritation.
OECD TG 492: Ocular Irritation Testing Use in vitro skin models to determine whether a product can cause dermal sensitization (e.g. EpiOcular Eye Irritation Test - EIT)
Real-time Stability Test Assure stability and physical integrity of consumer products in real-time conditions.

Other services

IND Writing Receive assistance with materials for an IND application.
NDA Writing Receive assistance in the NDA application process.

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