Dja Global Pharmaceuticals

The goal of DJA is to bridge the complex areas of discovery, pharmaceutical development and global regulatory science. DJA offers: 1. 100+ years collective experience in driving global regulatory approvals for drugs, biologics, combination products and devices. 2. Strategic and operational direction for product lifecycle management in all therapeutic areas. 3. Strategic due-diligence to achieve business objectives. 4. Results-oriented integrated product development involving CROs, CMOs and other external partners. 5. Resolving complex supply chain challenges and averting product recalls. 6. Developing and implementing GxP systems and managing successful agency inspections. 7. eCTD submission & publishing support services Since 2002, DJA has built long-term relationships with 25+ clients who have benefited from: - 8+ NDA/MAA/NDS approvals [including reversal of a non-approval action] in 5 therapeutic areas - 355+ agency submissions [IND/CTA/IDE] in over 30 countries - 40+ DMF/CEP submissions [human/veterinary products] in 28+ countries - 35 successful pre-approval inspections - led 45+ successful FDA/Canadian/EMEA meetings for 30+ products in all phases of development and 8 therapeutic areas