Comprehensive Regulatory & Compliance Support
Multidisciplinary Team, Global Vision
Navigating the regulatory maze is our specialty. Vireon Lab offers end-to-end regulatory affairs consultancy to ensure your pharmaceutical, biotech, OTC, or medical device products meet all local requirements in Pakistan. From product registration to post-approval compliance, we turn red tape into a strategic advantage.
Our experts guide you through the Drug Regulatory Authority of Pakistan (DRAP) procedures and other relevant bodies, so you can achieve approvals efficiently and maintain full compliance thereafter. We also integrate quality certification support – ensuring your operations adhere to Good Manufacturing Practice (GMP) standards, ISO certifications, and global quality benchmarks critical for trust and safety.
Are you planning to import or manufacture locally in Pakistan?
Contact UsProduct Registration & Licensing
Preparation and submission of dossiers for drug, vaccine, medical device registration, and import authorizations with DRAP. We handle communication with regulators to obtain drug marketing authorizations, medical device enlistments, import NOCs, and establishment licenses.
We liaise with legal and governmental institutions on your behalf when needed, giving you peace of mind in all regulatory dealings.
Quality Assurance & Certification
Guidance to achieve GMP compliance for manufacturing units, quality management system implementation (ISO 13485 for devices, ISO 9001, etc.), and support in obtaining necessary certifications or audits. We help ensure your products fulfill all quality standards, as required by regulators and expected by healthcare providers.
By entrusting Vireon Lab with regulatory, quality, and tax compliance, you minimize risk and delays.
Regulatory Maintenance
Ongoing compliance management including pricing compliance (DRAP-regulated medicine pricing, labeling reviews, periodic safety updates, and renewals so that your approvals remain valid and every change is accounted for. Our team anticipates regulatory changes and keeps your product in good standing post-launch.
We also assist in structuring import strategies in line with Federal Board of Revenue (FBR) regulations and any tax incentives.
