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Lower Cost Higher Efficiency and Quality — We are committed to delivering cost-efficient consulting services tailored to the specific needs of our clients. By combining a phase-appropriate approach with deep expertise in CMC analytical development, quality control, and related regulatory affairs, we significantly accelerate the development and manufacturing processes—resulting in reduced financial burden and shorter time to clinical study.
To further enhance cost transparency and efficiency, we only bill clients for actual, documented working hours—rather than standard office hours (e.g., 8 a.m. to 5 p.m.). Based on our experience, workloads can vary from day to day depending on the stage of the projects. For example, following the completion of the first GMP campaign and submission of CTD documents for IND/IMPD/CTA filing, daily support may require as little as a few hours, tremendously reducing costs for our clients.
Clients will receive a detailed breakdown of work performed and corresponding hours at the end of each business day. This accurate, transparent model tremendously lowers operating costs—especially for small and mid-sized pharmaceutical and biotech companies. Click the link to view a sample daily work hour tracking statement.
Customer Focus and Fully Customized Solutions — Customers' problems are our problems and customers' success is our top priority. We are committed to long-term relationships and clients' satisfaction is our most powerful driving force. We work fearlessly and tirelessly, embracing complex challenges with enthusiasm to help drive our clients toward lasting success.
We are firmly aware that each client has unique needs and priorities. That’s why our services are always tailored to align closely with their specific goals. Our customized approach ensures maximum efficiency and effectiveness, enabling us to meet CMC-related objectives without compromise.
Specialized Expertise and Proven Track Records — Our team brings strong expertise in analytical method development, quality control, stability as well as regulatory experience in related area, which are critical for the success of the projects from pre-clinical study through commercialization. We have multiple years of hands-on experience in critical analytical technologies including U/HPLC, GC, NMR, KF, FT-IR, LC-MS, Dissolution, Aw etc. Our expertise ensure that the analytical procedures are fit for their purposes and any analytical or quality control related issues can be resolved promptly and effectively.
We have successfully completed a number of GMP campaigns, gaining extensive hands-on experience in CMC. Our specialized expertise in CMC analytics and quality control, combined with a proven track record, enables us to reliably manage CMC activities and meet aggressive clinical timelines—allowing our clients to stay focused on their core business objectives.
Clear Communication and Commitment to Continuous Improvement — We recognize that effective communication is the cornerstone of successful collaboration. That’s why we prioritize clear, prompt, and consistent communication with our clients at every stage of the project. We provide full transparency into progress, challenges, and outcomes—empowering clients to make informed decisions and adjust goals or timelines without delay.
We enthusiastically invest in continuous learning, which drives our incessant improvement. By integrating the latest best practices, technologies, and strategies into our approach, we ensure our clients receive the highest level of service.
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