Our certifications from the world's most stringent health authorities validate our commitment to quality and enable seamless market entry across all Tier-1 regulated markets globally.
Every product manufactured at Bioplus meets the highest global standards — backed by rigorous inspections and ongoing compliance programmes.
One of the world's most respected regulatory bodies. Our MHRA approval enables direct supply to the UK market and is widely recognised globally as a benchmark of manufacturing excellence.
Certified by the Danish Medicines Agency (DKMA) under EU GMP standards, enabling market entry across all 27 EU member states and EEA countries — one of the world's largest pharmaceutical markets.
Health Canada approval authorises the supply of finished dosage forms to the Canadian pharmaceutical market, one of the world's most regulated and high-value markets.
TGA approval from Australia's Therapeutic Goods Administration enables product supply across Australia and New Zealand, opening access to the highly regulated Oceania market.
UNICEF Accredited Supplier, enabling supply to international humanitarian and global health programmes.
Social Audit Certification demonstrating responsible business practices, ethical supply chains, and worker welfare standards.
Customs-Trade Partnership Against Terrorism certification ensuring supply chain security for US-bound shipments.
Supplier Security Compliance Initiative certification ensuring ethical and secure supply chain practices across our manufacturing network.
Halal certification enabling supply to markets across the Middle East, Southeast Asia, and other Muslim-majority regions.
National Accreditation Board for Testing & Calibration Laboratories — validating our analytical laboratory capabilities to international standards.
All analytical and stability processes comply with ICH guidelines using Agilent OpenLab and CFR 21 Part 11 systems.
All manufacturing operations conducted under current Good Manufacturing Practice standards across all three facilities.
Quality is not just a regulatory requirement at Bioplus — it is embedded in our culture, processes, and people.
Every process is designed with regulatory submission in mind, using DoE and design space evaluation to ensure robustness and reproducibility.
100% data integrity across all analytical operations, maintained through Agilent OpenLab and CFR 21 Part 11 compliant systems with full audit trails.
Proven track record of successful regulatory inspections from MHRA, TGA, ANVISA, NAFDAC, and other authorities — always inspection-ready.