Project Support Services
BOC Sciences provides reliable guidance from concept to drug candidate, and our team of professionals has the knowledge and experience to assist you with everything from design proposals and market positioning to IP strategy and litigation support. We also conduct regular and ongoing quality assurance to ensure that your project stays on track. Our experts are intimately familiar with the technical, regulatory and legal complexities surrounding the pharmaceutical industry, applying sophisticated technology and a robust, analytics-based approach to help you navigate every element of the development process and preparation for your successful launch.
Figure 1. Small molecule, Phase 1 entry. (Earl S, D.; Groskoph, J. et al. 2015)
Our Services
To make it easier and better for researchers, BOC Sciences provides project support services service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
Product Lifecycle Management
BOC Sciences employs an efficient approach in the lifecycle management of each project, and our team applies risk-based scientific strategies to drug development and regulatory decisions. We strive to continuously improve and optimize our project lifecycle management capabilities. Equipped with a state-of-the-art online project management system, BOC Sciences has established standardized and effective project management mechanisms and workflows to ensure that all projects are conducted in an efficient manner
Figure 2. Large molecule, Phase 1 entry. (Earl S, D.; Groskoph, J. et al. 2015)
Technology Transfer
In general, the R&D of pharmaceuticals often requires technology transfer and scale-up. In particular, during the commercialization phase, as existing production cannot meet market demand, corresponding technology transfer process is required to establish new production lines or introduce new technologies to reduce production costs. At BOC Sciences, we provide technology transfer services throughout the entire production cycle of a drug product, from early development to clinical trial production. Our technical team provides a validated and reliable approach to technology transfer by employing a faster, simpler and more seamless technology transfer process with comprehensive and consistent support
Regulatory Strategy
BOC Sciences has over 20 years of experience in the field of new drug CMC development and has completed IND filings for several projects. We have accumulated extensive experience and provide comprehensive and professional regulatory support, including pre-IND meeting packets, IND filing documents, regulatory consulting and IND filings. Our experienced team can assist you in navigating the complex regulatory process and moving your project into the clinic and commercialization
Figure 3. Breakthrough therapy designation based on Phase 1 data. (Earl S, D.; Groskoph, J. et al. 2015)
Registration Management
BOC Sciences has built an experienced regulatory affairs team capable of providing comprehensive CMC services, including product changes, annual reports and re-registration services for investigational new drug applications. Our team can meet the regulatory requirements of major agencies around the world. As a result, we can provide comprehensive management of drug lifecycle regulatory services, from late stage clinical development to filing and post-approval commercialization
Figure 4. Breakthrough therapy designation based on Phase 2 data. (Earl S, D.; Groskoph, J. et al. 2015)
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of project support services at competitive prices for global customers. Personalized and customized services of project support services can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Earl S, D.; Groskoph, J. et al. CMC Considerations when a Drug Development Project is Assigned Breakthrough Therapy Status. PHARMACEUTICAL ENGINEERING. 2015.
