This package outlines the financial structure and market potential to help investors make informed decisions. We develop a comprehensive package that includes a business plan, feasibility study, and..
The step involves choosing the appropriate business structure, obtaining permits, and drafting documents. We manage the entire process of company registration, ensuring compliance with requirements.
Our technical team supports R&D by optimizing production processes through Quality-by-Design (QbD) principles. We help with cell line development, similarity assessments, and compliance with GMP.
We design and construct facilities that meet regulatory and operational standards. Our team helps with layout optimization, equipment selection, and facility modification to prevent costly delays.
We guide your project from early-stage small-scale production to large-scale commercial production, ensuring quality control at each stage and compliance with international quality standards.
We help manage pre-clinical studies to validate safety and effectiveness before human trials. We also assist with clinical trial applications (CTA) for each Phase, ensuring proper documentation.
Our team ensures regulatory compliance and accelerates the process to provide a reliable market entry and commercialization path. We prepare the Common Technical Document for regulatory authorities.
We implement safety monitoring systems to address adverse events and ensure ongoing compliance, helping maintain product trust and sustain long-term business growth.
