Vancouver-based CDMO delivering 70+ molecules, GMP-certified manufacturing, and AI-powered regulatory intelligence. Accelerate your development with unlimited CTD templates and expert advisory — $499/month.
70+ pharmaceutical products with complete technology transfer packages — master formulas, ICH stability data, and regulatory-ready CTD/eCTD dossiers delivered in 2–21 business days.
Once-weekly GLP-1 receptor agonist. Pre-filled pen and vial formulations. Complete master formula, 36-month stability data, CTD Module 3 templates. Ref: Ozempic® / Wegovy®.
First-in-class dual GIP/GLP-1 receptor agonist. Subcutaneous injection with complete analytical methods, forced degradation studies, and multi-market eCTD templates. Ref: Mounjaro®.
Anti-TNF-alpha monoclonal antibody. Citrate-free formulation option. Biosimilarity package with PK/PD data, regulatory dossiers for FDA 351(k), EMA Article 10(4), Health Canada.
Taxane chemotherapy for breast, ovarian, NSCLC. Conventional and nab-paclitaxel formulations. GMP batch records, validated analytical methods, complete oncology CTD package.
Anti-VEGF for neovascular AMD, diabetic macular edema. Intravitreal injection 0.5mg/0.05mL. Sterile fill-finish protocols and ophthalmic regulatory modules.
Platinum agent for ovarian, lung, head/neck cancers. 10mg/mL concentrate. Dissolution testing, impurity profiling, and full ICH stability documentation.
AI-powered CTD generation combined with 20+ years CDMO expertise across 70+ molecules — from GLP-1 biosimilars to complex oncology injectables and ophthalmic products.
Any molecule, any module. Module 1–5. 48-hour delivery.
Regulatory strategy, CMC, bioequivalence. From $500/hr.
FDA, EMA, Health Canada, TGA, PMDA, WHO prequalification.
Patent cliff analysis, competitive intelligence, market timing.
AI-powered CTD generation, compliance monitoring, and expert advisory — accelerating submissions from months to days.
GMP-certified facilities delivering pharmaceutical excellence since 2005.
Master formulas in 2–21 days. Complete documentation, stability data, and CTD templates via encrypted portal.
Biosimilars and oncology injectables. FDA, EMA, Health Canada, TGA, PMDA certified.
Method development, validation, and ICH-compliant stability studies.
Complex dosage forms: liposomes, nanoparticles, ADCs, sterile products.
CTD/eCTD dossiers for multi-market submissions. Regulatory strategy consulting.
End-to-end management, preclinical through Phase III, clinical batch production.
Contact our team. We respond within 24 hours with a detailed proposal.