Regulatory Consulting
Effective drug regulatory strategies can guide clients and reduce the time required for all phases of their drug programs from IND to NDA and BRA. Combining highly specialized industry knowledge with an appropriate regulatory approach, pharmaceutical companies are able to obtain approvals effectively and efficiently.
BOC Sciences' regulatory team consists of experts experienced in regulatory issues of antiviral drugs. We focus on the needs and requirements of our clients, and provide high quality services to meet their expectations. Through the combined efforts of our team, our regulatory consulting services enable you to maintain control over your route to market for antiviral drugs and stay ahead of any compliance risks.
Our Major Strengths
- Flexibility
- Experience in multidisciplinary projects
- Deep knowledge of the legislative and regulatory environment
Regulatory Consulting Service
BOC Sciences is committed to providing in-depth and regulatory-specific expertise to pharmaceutical innovators seeking product approval in key markets around the world.
- Document preparation
- DMF and ANDA submission
- Drug registration
- Expert execution
- BOC Sciences provides online support to pharmaceutical companies throughout the antiviral regulatory approval cycle. Our unique and powerful team includes CMCs, clinical experts, medical researchers, and industry operators who specialize in global regulatory approaches. We are confident that we can expertly guide you through the regulatory process, ensuring continuity and maintaining high quality
- Insight into regulatory requirements
- Our team is intimately familiar with the regulatory process for small molecule drugs and can provide valuable guidance to our clients, which is critical to developing optimal reporting materials and responses
- Our experts will guide you through the appropriate regulatory approach, and use their highly specialized industry knowledge to help you effectively obtain approval.
- In addition, combined with our robust regulatory intelligence, we are able to keep up with changing needs and proactively update filings as needed to ensure that changing regulatory standards do not cause delays in approval
- Support for all stages of the drug regulatory process
No matter where you are in the process of bringing your small molecule antiviral drug to market, we can provide the expertise and approval methodology to optimize regulatory compliance and documentation to help you bring your antiviral drug to market quickly and safely.
- Preclinical studies
We help you choose the best regulatory pathway, including an evaluation qualification program to accelerate antiviral drug development. Leveraging BOC Sciences' industry-leading experience, our team provides specific guidance and oversight every step of the way, from preparing the IND application, to writing the IND materials, and final submission of the IND application.
- Launch and safety monitoring
Our launch and safety monitoring services include post-approval study support, long-term pharmacovigilance, GM P audit support, and more to ensure your medications get to market as effectively and smoothly as possible.
Why Partner with BOC Sciences?
- We apply our years of proven expertise and experience in antiviral drug development to improve the success of your program
- Our continuously updated facilities support a range of antiviral drug analysis and manufacturing Synthesis & Manufacturing
- BOC Sciences' experienced team of scientists and regulatory staffs are focused on working with our clients to deliver timely and high-quality small molecule antiviral drugs
- Our partnerships with leading experts in emerging technologies allow us to apply innovative solutions to your antiviral drug research programs
※ Please kindly note that our services are for research use only.
