Welcome to Rysteril
Rysteril focuses on helping clients develop high-quality, cost-competitive and high-end sterile products for European and U.S. markets, such as complex generics, 505(b)(2) applications, and innovative drugs. We provide clients with comprehensive guidance, ranging from development to post-approval marketing management.
About Rysteril
Our Mission
At Rysteril, our mission is to assist clients in developing and producing high-quality, competitively priced, high-end sterile products to meet the increasing clinical demand.
Services
- Offering clients comprehensive consulting and guidance in all stages, ranging from new product R&D, process scale-up, project management, technical transfer, manufacturing, regulatory submission , product launch to post-approval marketing management.
- Assisting clients in establishing research and development teams, and platforms for injectable and ophthalmic products.
- Supporting clients in conducting market research for the European and U.S. markets, selecting products, and establishing new product development pipelines.
- Helping clients establish efficient product development process management systems and quality management systems.
- Assisting clients in establishing product sales channels in the European and U.S. markets, managing new product launches and post-approval marketing management.
Our Advantages
- We provide comprehenive and integrated consulting services, ranging from new product R&D to post-approval marketing management.
- Our experienced sterile product consulting team has a deep understanding of the industry, extensive experience, and is capable of resolving various challenges in clients' R&D processes.
- Our R&D is oriented towards the European and U.S. markets, with a focus on product competitiveness, prioritizing clients' interests and helping clients save time and money to efficiently develop high-quality and competitive new products.
- We can work directly in clients' laboratories, collaborating with the team long-term to identify and resolve issues on-site.
- Besides R&D consulting, we assist clients in selecting and initiating R&D projects for the European and U.S. markets, establishing strong new product pipelines, and selling products through our European and U.S. sales partners post-approval.
Collaboration
Project-Based Collaboration
- Fee by Project: We provide advisory services based on specific projects, charging according to project progress and workload.
- Phased Collaboration: The entire development process is divided into multiple phases. We provide specific services at each phase, from R&D to clinical trials to regulatory approval.
Long-Term Collaboration
- Long-Term Consulting Contract: We work with the client on a long-term basis, offering ongoing consulting services.
- On-Site Consultant: We work on-site at the client's company regularly or for extended periods, closely collaborating with the client's team to solve problems in real-time.
On-Demand Consulting
- Hourly Billing: We charge based on the actual time spent providing consulting services, suitable for companies needing occasional consulting.
- Specific Problem Consulting: We provide one-on-one solutions for specific technical or management issues encountered during the R&D process.
Training and Team Building
- Training Services: We provide regular training for the client's R&D team, enhancing their professional knowledge and skills.
- Team Building: We assist in forming and optimizing the R&D team, including recruitment, role setting, and team management.
Technical Platform and Process Development
- Technical Platform Development: We help the client establish and optimize technical platforms to enhance R&D capabilities.
- Process Development and Scale-Up: We offer process development and scale-up services to ensure a smooth transition from laboratory to production.