Product Lifecycle Management
Lifecycle management of technology and registration is beneficial to patients, industry and pharmacovigilance agencies, facilitating continuous improvement of biologic drug innovation and enhancing security and improvement of drug supply. Regulatory submission strategies play an important role in order to obtain early product approval/acceptance. Therefore, manufacturers consider professional regulatory consulting for the CMC lifecycle management of approved products. BOC Sciences employs an efficient approach to the lifecycle management of each project. Our team applies a risk-based scientific strategy to drug development and regulatory decisions. These methods are invaluable for evaluating CMC changes across the product lifecycle. We are able to keep registration files up to date in accordance with specific national requirements for product lifecycle management.
Advantages of Product Lifecycle Management
- Reducing post-approval filings related to Marketing Authorisation Application (MAA)
- Reducing associated registration efforts
Figure 1. QbD workflow. (Jose Menezes, J.; Madalena, R. et al. 2019)
Our Services
To make it easier and better for researchers, BOC Sciences provides product lifecycle management 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. Our project teams adhere to a customer-oriented approach. We strive to continuously improve and optimize our project lifecycle management capabilities. Equipped with advanced online project management system, BOC Sciences has established a standardized and effective project management mechanism and workflow to ensure that all projects are conducted in a efficient manner, and high quality products and services can be delivered on time
- The project management team coordinates, compiles, and provides reliable technical solutions and responds quickly to customer inquiries
- Our customer service team is mainly responsible for communication and follow-up of non-technical issues to ensure quality and efficiency
- Information about the entire process of a project is kept transparent to our clients so that each project can be understood in real time
- Upon project completion, the project management team archives project-related documents, such as reports and records, in a traceable manner
- We have established a client database and assigned dedicated teams to provide accurate and reliable service
- At BOC Sciences, continuous process improvement is performed to increase production and reduce the amount of waste
- Qualification of new suppliers of key starting materials to reduce supply chain risk and ensure sustainability of supply
- Systematic assessment of suppliers' risk levels through our well-designed supply chain risk assessment system
- Our expert teams change control management ensures that changes meet regulatory requirements throughout the product lifecycle
- Tracking of CMC Lifecycle management annual report for due date
- Provide regulatory strategies and timelines for required documentation for CMC lifecycle management
- Provide a list of changes implemented during the reporting period as well as CMC documentation
- Regulatory assessment of supporting documentation
- Request for additional documentation
- Authorization of the annual reporting package
- Track schedule for renewal applications
- Provide documentation requirements and timeline for CMC regulatory strategy
- Send the renewal initiation documentation requests to manufacturers and request for CMC documentation
- Conduct regulatory assessment of supporting documentation submitted for renewal applications
- Update the database with submitted details
Figure 2. Critical quality attributes (CQAs) to include in a QbD workflow. (Jose Menezes, J.; Madalena, R. et al. 2019)
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 product lifecycle management at competitive prices for global customers. Personalized and customized services of product lifecycle management 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
- Jose Menezes, J.; Madalena, R. et al. Is the QbD Toolbox Ready for Cell and Gene Therapies? Integrating Patient Outcomes into Manufacturing Cell and Gene Therapy Bioproducts. BioProcess International. 2019.
