Anabase International - Pharmaceutical, Biotech and Medical Device Product Development

At Anabase, we strategize for the development of New Drugs, New Devices and New Indications. We possess intimate knowledge of all aspects of Product Development, and a unique ability to assess and translate unmet medicals needs and product profiles into Clinical Development Plans, regulatory strategies, and business objectives.

Established in 1996, Anabase International is an extremely efficient product development consulting company specializing in drug, device, and drug / device combinations. At the service of our clients, we offer a winning combination of scientific brains and technical brawn to tackle every aspect of development. We engage in projects at their conception or en route, becoming integral to our client’s team.

We provide holistic and sustainable life-cycle management, guiding products from conception and needs assessment to development and regulatory plans with a keen focus on speed and efficiency. Anabase customizes each project, streamlining the development process and applying quick thinking and expertise for cost effective strategies.

We oversee trials, the submission process and approval to optimize the market launch, and the products’ long-term medical and financial benefits. Our professionalism and discretion achieve success for your company, your project, and your product.

Fortune 100 firms, mid-size companies, and start-ups in the United States and across the globe have entrusted us with running their most complex programs. We have a proven track record of success on a number of challenging and vital projects, and our dedicated focus and foresight helps us prevent issues before they happen, saving time and effort, further optimizing our clients’ investment in their products.

We know what works - and also what not to do - so our clients’ products grow, mature, and flourish to their greatest potential.

We are physicians, thus peers and respected interlocutors for key opinion leaders. As physicians, we ensure that the research we direct and oversee is medically sound. In conceiving clinical development plans, we consider the most advanced protocol design concepts such as adaptive designs, to ensure that clinical development proceeds with inherent proficiency. Furthermore, we consider product development with a long-term global perspective.

Anabase builds, joins and collaborates with research and development teams and international partners. Our contributions ensure successful negotiations and interactions with the FDA and other regulatory authorities.

Strategic planning

• Business development
• Business plan development
• Investor presentations
• Product and medical needs
• Product development
• Regulatory

Clinical Research – Phase I, II, III, IV studies, registries, post-marketing surveillance, rescue for troubled studies

• Trial design and protocol development
• Case report form design and production
• IRB submission
• Investigator meetings
• Informed consent form preparation
• Site support and training
• Core laboratory services / management
• Study monitoring and management
• Data entry, capture, validation and management
• Steering committee
• Clinical outcomes adjudication
• Data safety monitoring board
• Statistical planning, analysis, and reporting

Regulatory

• FDA negotiation and filing: IND, NDA, IDE, PMA, 510(k)
• Safety review and adverse experience reporting
• Safety and effectiveness summary preparation

Medical writing

• Clinical reports
• Presentations
• Publications
• Study protocols
• Informed consent forms

Information technology

Our Proprietary study management and data handling system, which has fully integrated clinical and regulatory modules, is internet-based, secure, and available 24 hours per day

Access is controlled and customized at the user level. The system supports both electronic and paper-based data, and is fully 21 CFR Part 11 compliant and fully auditable. We provide study site and start-up back-office operations support, as well as study-dedicated web-based support.