Indivirtus is the fastest growing, cost effective, service provider to Pharmaceutical, Healthcare, Insurance, Data management and Book Keeping Industry in a time bound manner. Indivirtus group comprises of
- Indivirtus Healthcare Services Pvt. Ltd.
- Indivirtus Solutions Pvt. Ltd.
- Indivirtus Strategic Solutions Pvt. Ltd.
- Indivirtus AB7 Scribing and RCM Pvt. Ltd.
Indivirtus Healthcare Services
The relationship between dose and its effects on the exposed organism is of high significance in toxicology. The goal of toxicity assessment is to identify the adverse effects of a substance. Factors that influence chemical toxicity include the dosage, route of exposure, species, age, sex, and environment.
- Exposure limit assessment (PDE/ADE)
- Genotox Evaluation of impurities
- GRAS report
- Safety data sheet (SDS) services
A New 24X7X365 Integrated Model A ‘Cost-Effective-Quality Driven’ Safety and Medical information Solutions provider: Our fully compliant MICC is integrated with our on-site DRUG SAFETY DATABASE. We provide strategic support to pharmaceutical companies for products throughout their entire lifecycle. We are reimagining the existing common industry’s model with a fully automated, cloud-based platform enabled with machine learning (AI based integration).
CSV and GxP Services
Our team of experts can manage development and implement entire Validation program for its Customers. We offer following services:
- GAP Assessment audits / Due Diligence Audits
- Vendor Assessment Audits
- Reduction of Operational Redundancies in Manufacturing & Quality Control
- Production Process Integration, Process Optimization & Yield Improvement
- CAPA, OOS and risk management with appropriate mitigation and contingency plan
- Managing Regulatory response & Remediation activities (USFDA & EU)
- Implementation and monitoring of Quality Systems compliance based on FDA's six quality systems approach
- People development through training and demonstration
- Health Hazard Evaluation
- PLC Validation
- CSV Validation
- Equipment Qualification
- HVAC & Clean Room Validation
- Compressed Air Validation
Formulation Development & Tech Transfer
- Delayed Release Formulations
- Oral Disintegrating Formulation
- Multi Unit Particulate Systems (MUPS)
- Nutraceutical Formulations
- Solubility / Bioavailability Enhancement
- Injectable Formulations
- Technology Transfer
- Diagnostic Antigen
- API by Fermentation Technology
- ICH Stability and Photostability study
- Molecular Reagents & Antibodies
Regulatory Medical and Clinical Writing Services
- New Product Authorization- IND, NDA, ANDA
- Post Approval Changes and Product Lifecycle Management
- Clinical and Non-Clinical Overviews
- Clinical Expert Statements
- Bio waiver Expertise
- eCTD/CTD dossier compilation
- Investigator Brochures
- Clinical Study Protocols
- Clinical Study Reports (CSRs)
- Informed Consent Documents
- Patient Safety Narratives
- Clinical Evaluation Reports
- (CER) for Medical Devices
Phase III and Phase IV (Post Marketing Surveillance) trials
We have competency in handling complex clinical trial designs (hormones, endogenous substances, elemental formulations and locally administered products) besides oral solids/liquid dosage forms.
Our experienced team is capable of executing complex studies in different therapeutic areas and phases across various geographies. We ensure planning and execution to ensure high quality and timely deliverable.
- Reporting of adverse events and serious adverse events.
- Medical query and its resolution for protocol compliance
- Accurate data collection and GCP compliance
- Regulatory reporting for safety issues as per regulatory requirements
Food Safety (HACCP)
We provide expert advice and scientific consultation to stakeholders involved in bringing food and beverage from “farm-to-table” such as producers, manufacturers, suppliers, distributors, retailers, food service solutions etc.
We have great team of board-certified toxicologists who are qualified by education and practice to perform various food safety evaluations.
Our services include but not limited to:
- Generally Recognized as Safe (GRAS) Dossier Preparation & Notification.
- Cumulative Estimated Daily Intake (CEDI) Assessment.
- Hazard Analysis Critical Control Points (HACCP)
- Acceptable Daily Intake (ADI) Assessment.
- Dietary Intake Assessment.
- Functional barrier and food migration studies.
- Safety assessment on food packaging inks, coatings, glues.
- BfR Recommendations on Food Contact Materials.
- Non-Intentional Added Substance (NIAS) assessment.
- Safety assessment of Food Allergens and Impurities.
- Restricted and prohibited substances screening and recommend phaseout strategies.
- Labeling & Claims Substantiation.
- Technical & Scientific Writing & Publications.
- White Papers & Monographs.
- Expert Testimony & Litigation Support.
- General Food Safety Consulting Services.
- We provide proof of concept to global submissions in an ethical, efficient and regulatory compliant manner.
- Indivirtus offers specialized solutions in pharmacokinetic and statistical analysis.
- Regulatory support including e-CTD compliant dossier submissions and resolving regulatory queries.
- Competency in handling complex clinical trial designs (hormones, endogenous substances, elemental formulations and locally administered products) besides oral solids/liquid dosage forms.
- We strictly comply to current GCP/GLP guidelines.
- Our team is competent in handling different analytical challenges including pro-drug analysis, parent–metabolites simultaneous assays, chiral analysis, elemental analysis, hormones and endogenous substances.
- State-of-the-art Bioequivalence Facility with well-equipped pathology laboratory.
- Healthy adult male and female volunteers including post-menopausal women.
- More than 200 methods developed and validated from various biological matrices like blood, plasma, serum etc.
Indivirtus Strategic Solutions
Export/ import of finished formulations
Finding a suitable MAH across all regions
Indivirtus offers back-office outsourcing services on both Personal & Commercial Lines insurance to Agencies, Brokers, MGA’s, Wholesalers and Carriers across the globe. Our insurance process outsourcing services can help you put together a foundation not just for effectual change, however for long-term high performance. Consider us as your support team that looks after all the day-to-day and time-intensive tasks, so your in-house team can pay attention to other core activities.
Ensure your books are in balance and error-free with the help of our expert team of accounting specialists having worked on platforms like QuickBooks (Online/Desktop), NetSuite, AMS360, Xero, Bill.com, ADP and Gusto. Learn More
Data Management Services
As corporations collect large amounts of customer, product, transaction, market and social data, it becomes very important to manage, maintain and make sense of the data collected to get desired insights out of it. Learn More
Indivirtus offers innovative, value added customer-centric support and solutions. Some of the attributes of our Call Centre services are as follows: