Registration Management

BOC Sciences has an experienced regulatory affairs team capable of providing comprehensive CMC services including product change, annual reporting and re-registration services for investigational new drug applications (IND/CTA) and their clinical trial phases, as well as for all phases of new drug applications. Our team is well acquainted with the regulatory requirements of all major agencies worldwide. We can provide comprehensive drug lifecycle services management from late stage clinical development through filing and post-approval commercialization. Our regulatory affairs group can provide gap analysis and relevant CMC data in CTD format and other required formats when needed.

Figure 1. Regulatory Requirements for Registration of Pharmaceutical Drugs. (Mohit; Deep, A. et al. 2019)

Our Services

To make it easier and better for researchers, BOC Sciences provides registration 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. We are committed to providing clients with comprehensive registration support services throughout the drug development life cycle. Our services start with the formulation of the drug regulatory registration strategy, including the preparation, revision and submission of registration documents. Based on the professional expertise of our consultants, BOC Sciences can submit electronic and paper documents in the fastest and most professional way, and ensure that the registration documents meet the strictest regulatory requirements.

• Simultaneous assessment, planning and feasibility consulting
• Compliance guidance and support during critical CMC production
• CMC application material preparation and technical review
• Pharmaceutical data registration support for IND, NDA, ANDA
• Customized application services for different pharmaceutical products
• Translation services for filing materials
• Ensure the quality of filing materials to meet the filing requirements
• Submit materials and maintain good communication with authorities
• Global pharmacy strategies and clinical strategy plans
• Gap analysis and review of formulation and API registration file
• Preparation of DMF, ASMF, CEP registration documents in eCTD or NeeS format
• Preparation of product registration documents (quality section)
• Expert reports, overviews and summaries and clinical trial drug files
• Pre-clinical and clinical component surveys of dossiers
• Application of file changes
• Electronic submission support
• New molecular entity, new biological ingredient, new dosage form development program design support
• New Drug Clinical Trials (IND), New Drug Applications (NDAs) (CTDs) and Generic Drug Applications (ANDAs) feasibility assessment, complete Marketing Authorization Application (MAA) support in accordance with relevant laws
• Pharmaceutical and clinical strategy master plans, expert presentations, overviews and summaries
• Pre-clinical and clinical drug component bioequivalence study design and document review
• Drug development training support and drug registration

Figure 2. Registration workflow. (Kumar, P.; Mangla, B. et al. 2017)

Features of Our Registration Management

• Closely communicate and interact with customers
• Fully understand the needs and requirements of customers
• Formulate corresponding reporting strategies
• Registration plan in different regions

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 registration management at competitive prices for global customers. Personalized and customized services of Registration 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!

References

1. Mohit; Deep, A. et al. Comparison of Regulatory Requirements for Registration of Pharmaceutical Drugs in Asean and GCC Regions. Applied Clinical Research. 2019. 6(1): 62-70.
2. Kumar, P.; Mangla, B. et al. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT. IAJPS. 2017. 4(12): 4705-4719.