Antiviral Drug Regulatory Services
Concerns about the efficacy and safety of drugs have led most governments to establish regulatory agencies to oversee the development and marketing of drugs and medical devices. The application of any drug poses some degree of risk of adverse events, therefore, effective drug regulation is required to ensure the safety and efficacy of drugs for the public. Nowadays, many national drug regulatory authorities follow special approval procedures for antiviral drugs in accordance with the relevant provisions of the Drug Administration Law. In addition, the State Drug Administration requires the holder of the marketing license to continue the relevant research work, complete the requirements of the attached conditions by a deadline, and submit the results of the follow-up studies in a timely manner.
BOC Sciences' pharmaceutical product regulatory team is comprised of experts experienced in all antiviral drug regulatory issues. We focus on the needs and requirements of our clients, providing high quality services that meets their expectations.
Our Capabilities
- We help our clients continually find new ways to improve efficiency and save costs to ensure the competitiveness and quality of their products entering the marketplace
- Our team is committed to optimizing processes wherever possible to improve commercial success
- We also provide the data needed in relation to any process changes to ensure ongoing regulatory compliance
- BOC Sciences' global regulatory affairs team provides CMC file support for IND, CTA, MAA and NDA applications. Our experienced team can prepare regulatory dossiers for you, adding tremendous value to your development program and accelerating time to market
- By understanding key regulatory recommendations, we provide consulting to assess strategy, planning and feasibility
- We can assess filing preparation and ensure the quality of source documents ready for regulatory submission
- Our highly skilled team of professionals has in-depth regulatory knowledge and a thorough technical and quality control review in-house prior to client review
BOC Sciences Features
- Flexibility
- Multidisciplinary project experience
- Excellent relationships with health authorities
- In-depth knowledge of the legislative and regulatory environment
- Expertise in electronic submissions
Comprehensive Services
BOC Sciences' antiviral regulatory affairs team is a scientific and regulatory advisory group, and we can guide and assist pharmaceutical companies in the design and implementation of innovative global regulatory strategies to accelerate the development and registration of antiviral drug products at all stages of development. We provide regulatory consulting support for antiviral drug products at all stages of development, from pre-clinical to post-marketing. We have accumulated rich experience in working with various pharmaceutical companies to bring different antiviral drug products to market in the most efficient and cost-effective manner.
A consistent and compliant regulatory dossier is key to timely clinical trial approval and successful marketing authorization. Our dossier development team helps you accelerate the antiviral drug approval process. At BOC Sciences, our quality team ensures that our clients have the drug product information they need to assure the regulatory agencies in the target markets that the materials used are in compliance with applicable quality rules.
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 services
- 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.
