Comprehensive CRO Services for Pharma, Biotech & Medical Devices

Our comprehensive ADE (Acceptable Daily Exposure), PDE (Permitted Daily Exposure), OEL (Occupational Exposure Limit), and OEB (Occupational Exposure Banding) calculation services provide the scientific foundation for effective cleaning validation protocols. We help pharmaceutical manufacturers establish safe exposure limits that protect both patients and workers from harmful API residues. Our toxicological assessments comply with EMA guidelines, ICH Q3D standards, ISPE best practices, and other leading international regulatory frameworks, ensuring your facility meets the highest safety and compliance standards.

Our containment validation services ensure your pharmaceutical isolators provide maximum protection for operators and the environment when handling highly potent compounds (OEB 3+). We establish clear containment performance targets, conduct thorough surrogate powder testing, and perform comprehensive air, personal, and surface sampling at all critical control points. All samples undergo rigorous analysis at AIHA-accredited laboratories, with the entire process overseen by Certified Industrial Hygienists following strict ISPE SMEPAC guidelines and cGMP best practices for complete regulatory compliance.

Indivirtus provides end-to-end pharmacovigilance (PV) support as part of its CRO services for the pharmaceutical industry. From setting up PV systems and handling ICSR case processing to preparing PSMF, PSUR, and Risk Management Plans, our solutions are aligned with global regulatory standards (EMA, US FDA, WHO). Our team ensures your products meet all compliance requirements while protecting patient safety through vigilant signal detection, literature monitoring, and spontaneous reporting systems.

Getting your pharmaceutical or medical device to market shouldn't be a regulatory maze. Indivirtus offers clear strategic and technical guidance for your global submissions. We handle everything from compiling and submitting CTD/ACTD dossiers and DMF/CEP files to agencies like the FDA and Health Canada, to registering your medical devices under the latest MDR 2017 standards. Facing regulatory hurdles? We manage complex agency responses and remediation plans for you. We can also serve as your Marketing Authorization Holder (MAH) or Qualified Person (QP), and facilitate EU batch releases, ensuring your product not only complies with all regulations but also gets to market faster.

Indivirtus offers end-to-end assistance for pharmaceutical facilities seeking GMP approvals from global regulatory bodies such as EU-GMP, USFDA, WHO-GMP, PIC/S, TGA, Health Canada, GCC, ANVISA (Brazil), and COFEPRIS (Mexico). Services include vendor assessment audits, plant design and infrastructure evaluations, validation and calibration checks, documentation reviews, and GAP assessments as per Schedule M and international GMP guidelines. Our experts help prepare for regulatory inspections with tailored remediation and compliance strategies.

Indivirtus offers a full suite of validation and qualification services in support of pharmaceutical CRO operations. We validate computerized systems (CSV), laboratory instruments (HPLC, GC, FTIR, etc.), process automation platforms, environmental monitoring, enterprise software (LIMS, ERP, SAP), HVAC systems, and perform temperature mapping for critical zones. Our services ensure compliance with FDA, EMA, WHO and GMP standards, mitigating operational risk and ensuring data integrity.

At Indivirtus, we offer comprehensive QA support throughout your Bioanalytical, Pre-clinical, and Clinical studies. Our team helps you maintain GCP, GLP, and NDCT 2019 compliance while safeguarding scientific integrity, ensuring data reliability, and building confidence with global regulators.