Our Services.

At Abphina, we understand that the best compliance framework begins at the start of product development and runs through the entire product lifecycle. This provides 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. The size of the support depends 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.

Medical and scientific writing plays a crucial role in all aspects of a product’s regulatory journey. It is the glue that connects all stakeholders, using carefully curated language to provide 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 a smooth process. We strictly adhere to our in-house writing process to help deliver writing projects for submission to regulatory agencies and other pertinent stakeholders.

Our expertise includes clinical study protocols, clinical study reports, clinical evaluation report, Investigator Brochures, IND/IDE/BLA Application, and scientific literature review.

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:

Clinical Project Management

Study Design and Protocol Development

Clinical Development Plan

Digital Health Integration

EDC Setup & Study Monitoring

IRB/EC Submissions

Designing a robust risk management program is pivotal to effective product lifecycle management.

Abphina specializes in helping 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.