Regulatory & Compliance Support
Ensure full compliance across 40+ jurisdictions with InnovRx’s dedicated regulatory affairs team — protecting your products, licences, and market access.
Overview
Regulatory non-compliance is the single biggest risk to your global market access. A failed inspection, lapsed registration, or labelling violation can result in product recalls, import bans, and reputational damage. InnovRx’s Regulatory & Compliance Support service is your proactive shield against these risks.
Our regulatory affairs team maintains continuous oversight of your compliance status across every market — managing registrations, monitoring regulatory changes, and coordinating with local authorities to ensure uninterrupted, compliant operations.
“Compliance is not a static endpoint; it is an ongoing discipline of vigilance, accurate documentation, and proactive adjustment to evolving local standards.”
A Structured 6-Step Process for Absolute Compliance
Regulatory Landscape Analysis
Comprehensive mapping of regulatory requirements in each target market: applicable legislation, competent authorities, registration frameworks, labelling standards, and post-market surveillance obligations.
Compliance Gap Assessment
Audit your existing products, documentation, and processes against applicable regulatory requirements. Identify and prioritise compliance gaps requiring remediation.
Registration & Dossier Management
Prepare, compile, and submit complete regulatory dossiers for product registrations, import licences, and establishment licences. Manage all authority interactions through to approval.
Labelling & Documentation Compliance
Review and adapt product labels, package inserts, and promotional materials to comply with local regulatory requirements — including language, safety warnings, ingredient declarations, and claims compliance.
Post-Market Surveillance & Pharmacovigilance
For pharmaceutical products, establish and manage pharmacovigilance systems, adverse event reporting, and periodic safety update reports (PSURs) as required by local authorities.
Regulatory Intelligence & Change Management
Continuously monitor regulatory changes across all markets. Proactively communicate impending changes and manage required updates to registrations, labels, and processes before deadlines.
Industry Specialisation
Pharmaceuticals
Pharmaceutical regulatory compliance requires GMP certificates, pharmacovigilance systems, CPPs, dossier submissions in CTD format, and ongoing PSUR reporting. We manage the full regulatory lifecycle for Rx, OTC, generic, and biologic products across 40+ jurisdictions — including EMA, FDA, Health Canada, WHO, and national authorities.
Cosmetics
Cosmetic compliance involves ingredient compliance (EU banned list, US FDA, GCC), CPNP notifications, safety assessments, labelling compliance, and claims substantiation. We navigate the EU Cosmetics Regulation, US FDA OTC framework, ASEAN harmonised standards, and GCC cosmetic regulations on your behalf.
Key Benefits
Common Queries About Regulatory & Compliance
Q. What regulatory frameworks do you work with?
EMA (EU), FDA (US), Health Canada, SFDA (Saudi Arabia), CDSCO (India), TGA (Australia), WHO, and 30+ national authorities.
Q. Do you manage pharmacovigilance for pharmaceutical products?
Yes — we set up and manage PV systems, adverse event reporting, and PSUR submissions as required.
Q. How do you track registration expiry dates?
We maintain a centralised registration database with automated renewal alerts and proactive submission scheduling.
Q. Can you handle regulatory submissions in non-English speaking countries?
Yes — we work with certified translators and local regulatory consultants in all major markets.
Q. What is your compliance rate?
We maintain a 99% compliance rate across 500+ active product registrations globally.
Q. Do you conduct GMP audits of manufacturing facilities?
Yes — we conduct pre-submission GMP audits and help facilities prepare for regulatory authority inspections.
Q. How quickly can you respond to regulatory authority queries?
We provide 24-hour initial response capability for urgent regulatory queries across all connected markets.
Q. Do you handle cosmetic safety assessments?
Yes — we coordinate cosmetic safety assessments with accredited toxicologists as part of our compliance service.