Group Companies and 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

• Pharmacovigilance


• Materiovigilance


• Cosmetovigilance


• Veterinary Vigilance

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).

• 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


• Calibration

• Delayed Release Formulations


• Oral Disintegrating Formulation


• Multi Unit Particulate Systems (MUPS)


• Nutraceutical Formulations


• Solubility / Bioavailability Enhancement


• Injectable Formulations


• Technology Transfer


• Biosimilar


• Diagnostic Antigen


• API by Fermentation Technology


• ICH Stability and Photostability study


• Molecular Reagents & Antibodies

Regulatory Writing

• 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

Clinical Writing

• Investigator Brochures


• Clinical Study Protocols


• Clinical Study Reports (CSRs)


• Informed Consent Documents


• Patient Safety Narratives


• Clinical Evaluation Reports


• (CER) for Medical Devices

• 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

• 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.