US Agent Services: Finding an experienced US Agent with a sterling reputation is an essential element of any successful international expansion effort. Biologics Consulting:

• Acts as the US Agent for more than 100 applications, including pre-INDs, INDs, BLAs, NDAs, ANDAs, Master Files and requests for Orphan Drug Designation (ODD),
• Effectively and professionally represents client organizations throughout the nuanced process of engaging with the FDA,
• Liaises with the FDA on behalf of Sponsors at meetings and via regular correspondence with the Agency during the entire lifecycle of a product.

Medical Writing: Our team of experienced medical writers delivers:

• Clear, well-organized, compliant and scientifically valid content,
• Decades of experience in the preparation of IND documents, clinical study protocols, clinical study reports, and marketing applications,
• Project planning services to ensure efficient execution of even the most complex projects, such as NDA and BLA submissions,
• Support in all aspects of marketing applications, including review and editing, safety narratives, input on Statistical Analysis Plans and data pooling plans, and QC services.

Project Management: An organized and efficient project manager can be the difference maker in the execution of a successful project. Biologics Consulting Regulatory Project Managers:

• Have a strong knowledge of FDA regulations, guidance and expectations based on direct experience,
• Interact with FDA project managers and reviewers on a daily basis as the primary point of contact for US Agent clients,
• Follow trends within Centers and Divisions with regard to current practices,
• Provide regulatory and product development guidance,
• Serve as a primary point of contact for project coordination,
• Coordinate writing, review, strategy discussions, publishing and application life cycle maintenance activities,
• Advise on optimal practices to create efficient, reviewer friendly applications,
• Provide regulatory and submission guidance,
• Accompany Sponsors to FDA meetings and participate in teleconferences.

Electronic Publishing & Submissions: The electronic publishing and submissions group provides clients with an array of tools and services that enhance collaboration, streamline the application drafting process, and reduce regulatory review times.

We provide our clients with:

• Customizable, compliant document templates,
• Complete, reviewer-friendly submissions in a guidance-compliant eCTD structure,
• Reliable and secure transmission of documents to FDA via our Electronic Submissions Gateway (ESG),
• Maintenance of applications throughout the eCTD lifecycle, ensuring that reviewers have the latest information at their fingertips,
• Assistance in transitioning existing paper and NeeS (non-eCTD electronic submissions) applications to eCTD format.

Staff Augmentation: For many biotechnology companies, maintaining a full complement of product development experts, from nonclinical researchers to clinical trial experts, medical writers and regulatory professionals is not possible. However, lacking access to these experts hinders the progress product development.

Biologics Consulting has designed a unique solution to address this issue with our Staff Augmentation offerings. Our team is comprised of former industry scientists and FDA reviewers who adhere to the highest standards of professional conduct. We:

• Employ a full roster of consultants in every area of pharmaceutical, biologic/biosimilar, medical device, and therapeutic product development,
• Offer our clients the opportunity to make our team yours, on-demand,
• Provide a team able to step in to augment your current team, providing you with the benefits of a world-class staff at a fraction of the cost,
• Work with firms of all sizes on projects of all magnitudes,
• Bring a unique insider perspective to each engagement, allowing you to maximize the value of every dollar spent while accelerating your development timeline.

Due Diligence: Information is the key to managing risk. Biologics Consulting's Due Diligence services draw on deep experience and understanding of the regulatory and product development requirements for success, to:

• Help our clients make informed business decisions,
• Provide professionals to perform comprehensive due diligence on the strategic and operational realities of the target,
• Serve: Venture Capitalists, M&A Parties and their Advisors, Industry Venture Groups, Business Development Departments, Alliances and Co-Development Partnerships.