Regulatory Affairs
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 Writing
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 smoothprocess. We adhere strictly to our matured in-house writing
process to help deliverwriting project for submission to regulatory agencies
and other pertinent stakeholder. Our expertise includesclinical study protocols,
clinical study reports, clinical evaluation report, Investigator Brochures,
IND/IDE/BLA Application, literature reviewsummaryetc.
Digital Health
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 areacontinue to grow, we stand prepared to help
youmanage future development and integration of digital health solutions.
Data Science
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.
Clinical Operations
When we think of clinical services, we think of patient safety, strategy, and compliance.
Abphina clinical services provide design and operational expertise for clinical investig-
ations meeting ICH-GCP guidelines. Our network includes clinical trial experts in drug,
device and combination products. We work closely with clients during planning, imple-
mentation, and execution. For complex studies, we also help with clinical supply
sourcing and vendor management. Specific areas of expertise include:
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Clinical Project Management -
Study Design and Protocol Development -
Digital Health Integration -
EDC setup & Study Monitoring -
IRB/EC Submissions
Risk Management
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.
