At Abphina we understand that the best compliance framework is the one that starts at the beginning of product development and runs through the entire product lifecycle providing a continuous value delivery system that accompanies your product from clinical development right through to post-market surveillance. Abphina works with biopharmaceutical and medical device manufacturers to offer end to end service delivery or customized solutions with various levels of support depending on factors like the stage of the development cycle, product portfolio size, level of engagement required, internal capacity or geographical distribution of markets. We also work with clients who are out of compliance and require remediation efforts to gain back and maintain compliance status. For additional details on our regulatory affairs services, please select from the list below for more information.

Medical and scientific writing plays a crucial role in all aspects of a products regulatory journey. It is the glue that connects all stakeholders using carefully curated language to provide just the precise message for diverse audiences. Our expertise lies in presenting complex ideas in a clear and comprehensive manner. Lending to our extensive regulatory influence, our team of seasoned writers will work hand in hand with you throughout your regulatory journey to facilitate smooth process. We adhere strictly to our matured in-house writing process to help deliver writing project for submission to regulatory agencies and other pertinent stakeholder. Our expertise includes clinical study protocols, clinical study reports, clinical evaluation report, Investigator Brochures, IND/IDE/BLA Application, literature review summary etc.

Our digital health innovation service solution explores best practices for integrating digital technologies into product portfolios. We manage a broad range of digital health product development including wearable devices, mobile health (mHealth), health information technology (IT), telehealth and telemedicine, and personalized medicine. We provide the necessary support to explore digital health options to deliver and manage therapies. Key areas of expertise include clinical safety engineering, cybersecurity, and regulatory assessment of digital health solutions. Our experience working with multiple platforms and therapeutic areas is an invaluable organizational asset that we believe brings value to our clients. As the digital health knowledge area continue to grow, we stand prepared to help you manage future development and integration of digital health solutions.

Abphina continuously researches various aspects of Technology Management and Innovation. Data Science and Data Management Research is one of the core competent areas Abphina uses to conduct feasibility studies and drive innovation. Abphina uses machine learning and data visualization programing to discover novice methods for large-scale data mining and management. The aim is to help accelerate discovery science to finished products. Our research includes bioinformatics, medical science, engineering, and business analytics. We also help organizations with predictive analytics, machine learning, and overall data process optimization. Z-Satellite® a post-market data analytics software, is one of the products from our data science research group. Z-Satellite® is a one-of-a-kind post market surveillance software with emphasis on safety and the voice of the customer.

When we think of clinical services, we think of patient safety, strategy, and compliance. Abphina clinical services provide design and operational expertise for clinical investigations meeting ICH-GCP guidelines. Our network includes clinical trial experts in drug, device and combination products. We work closely with clients during planning, implementation, and execution. For complex studies, we also help with clinical supply sourcing and vendor management. Specific areas of expertise include: (1)Clinical Project Management, (2)Study Design and Protocol Development, (3)Digital Health Integration, (4)EDC setup & Study Monitoring, (5)IRB/EC submissions.

Designing a robust risk management program is pivotal to effective product lifecycle management. Abphina specializes in supporting clients manage risk at each product development milestone, using quality by design principles. Our expertise includes electrical safety assessment, biological evaluations, and software risk management. Our staff will provide expertise in risk-management methods used in product design and manufacturing focusing on harmonized standards and guidance. From risk planning to risk mitigation strategies, we poised to support you in identifying solutions to critical to safety design space elements. Our service options include helping clients identify and procure electronic tools to manage a risk management program