Regulatory Strategy
One of the most common challenges faced by the biopharmaceutical industry is how to optimize the investment of time and money, and how to effectively achieve compliance initiatives. Professional regulatory consulting support and a clear regulatory strategy are one of the most important factors in the commercialization of products throughout the drug development process. BOC Sciences is committed to being a reliable regulatory consulting partner. With a proven track record of keeping pace with global market conditions and guiding clients through their unique regulatory requirements, we have become the preferred registration consulting and strategic partner for any pharmaceutical or biotechnology companies.
Figure 1. Estimated global approval times for major changes. (Kutza, J.; Edwards, J. et al. 2017)
Our Services
To make it easier and better for researchers, BOC Sciences provides regulatory strategy 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.
- Regulatory resolution of drug development issues: impurities, analytical, stability, container closure related issues, etc
- Strategic planning for global clinical trials during drug development
- Strategic planning of regulatory applications by the time of submission, using the minimum available data or anticipated regulatory risk
- Strategic planning for bringing a product approved in one region to other regulated markets
- Submission planning for a variety of regulatory applications in the global market
- CMC consulting support preparation and submission of regulatory filings for IND, NDA, ANDA, MAA, NDS, ANDS, DMF, ASMF, IMPD, etc
- Compliance consulting for resolving agency inquiries
- Preparation and submission of Biological License Applications (BLA)/MAA for recombinant therapeutic proteins, vaccines and other bio-advanced therapeutic products (e.g. stem cells and tissue products)
- Regulatory compliance counseling for implementation of post-approval changes
- Regulatory consulting for pre-submission interactions with the HAA
- Competitor assessment and regulatory strategy/mitigation plan to accommodate the accelerated procedures prior to product registration
- CMC consulting for quality by design (QbD) protocols and reporting
- RA consulting for combination product (device+drug/biologic) development issues
- Compliance consulting for testing/risk assessment in determining genotoxic impurities, elemental impurities, etc
- Regulatory strategy and reference medicine (RMP) determination for global markets
- Our manufacturing processes comply with international regulations for current Good Manufacturing Practices (cGMP), and our manufacturing sites have been inspected by multiple national health authorities, allowing our products to be used by customers in the US, Europe, Asia and many other regulated markets
- Customized manufacturing operations are developed based on a process oriented quality management system with international
Figure 2. Contents of a chemistry, manufacturing, and controls dossier. (Kutza, J.; Edwards, J. et al. 2017)
Features of Our Regulatory Strategy Services
- Comprehensive regulatory support services, starting with process development plans to support toxicology study materials, through preparation of CMC information for IND filings and revisions
- Decades of experience in the analysis of biological materials
- Our staff provides CMC regulatory assistance in all aspects of our clients' projects, including meeting with regulatory agencies to discuss CMC development as well as CMC manufacturing and testing issues
- We have extensive experience in submitting DMFs for active pharmaceutical ingredients, drug products and IND’s for biologic products, and experience in testing over 150 recombinant proteins and monoclonal antibodies in accordance with FDA and EU requirements
- BOC Sciences strictly adheres to the regulations associated with the development of each new pharmaceutical ingredient and biologic product
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 regulatory strategy at competitive prices for global customers. Personalized and customized services of regulatory strategy 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
- Kutza, J.; Edwards, J. et al. Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum). BioProcess International. 2017.
