Our Services
ABR provides a full range of consulting and technical services to the pharmaceutical, medical device and diagnostics, and over-the-counter (OTC) industries.
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Whether you need expert advice to ensure success or simply another set of hands to get things done, the ABR team can step in to fill the gap. We can assist where needed at any stage of your product’s commercialization journey; from initial design to regulatory approval, launch, and in-market compliance support. Our comprehensive portfolio of services ranges from guidance and advice to on-site collaboration and training to turnkey delivery, and covers issues routinely encountered in everyday operations.
​ABR’s audit and gap assessment services enable clients to stay a step ahead of the game by preparing for future FDA inspections, ensuring their processes and systems meet FDA or other essential regulatory requirements, and creating an action plan to address any gaps. ABR’s audit team works closely with regulatory and clinical team members to create an audit strategy that is aligned with client priorities and needs.
Quality Systems & Compliance
​ABR’s Quality Systems and Compliance team supports manufacturers as they strive to align their processes with regulatory standards, ensure optimal product quality and safety, and increase efficiencies. From providing support for specific compliance issues to design and development of new procedures to staff training, ABR provides the expertise and guidance that companies need to establish and maintain best practices for quality control.
Regulatory Services
ABR provides the guidance you need to accelerate commercialization. From submissions to FDA coaching and representation, ABR’s team of experts will enable you to get your product to market quickly and efficiently. We work extensively with both U.S. and European regulatory agencies to support our clients.
Clinical Services
ABR can assist clients throughout all stages of clinical research – from planning and site selection to regulatory submission and post-market. ABR’s team of PharmDs, PhDs and other highly qualified medical professionals provide the expertise that clients need to conduct clinical research safely and effectively.
Medical Writing
ABR’s medical writing services team supports clients in preparing the documentation they need for regulatory submission and approval, clinical trial documentation, and much more. With extensive medical, therapeutic, and pharmaceutical backgrounds, our medical writing professionals know how to present and interpret data clearly and concisely to ensure all communication materials are accurate and compliant with the appropriate regulations and industry best practices.
Software Compliance
Technology products require just as much attention to regulatory needs as tangible products like medical devices or pharmaceuticals. ABR provides the support that software and systems providers need to ensure regulatory compliance, accelerate the approval process, and establish strong quality control processes.