25+ Years of Global Experience
4,100+ Clients Supported World-Wide
Client engagements from 58 Countries Around the World
Serving Clients Around the World
Having provided services to clients in 58+ countries worldwide, our international network of FDA regulatory consultants and affiliates are able to assist clients near and far to navigate the cumbersome regulatory and product development process. From gaining access to a new market to finding a manufacturing partner with acceptable facilities, our team has the knowledge and experience to help your team get the job done.
Biologics Consulting is proud to offer the full scope of regulatory and product development consulting services to our clients around the globe. In the map below, purple indicates a country in which we’ve served at least one client.
U.S. AGENT SERVICES
Acts as the US Agent for more than 100 applications
Effectively and professionally represents clients while engaging with the FDA
Liaises with the FDA on behalf of Sponsors via regular correspondence.
FDA MEETING PREPARATION & ENGAGEMENT
Represents clients in interactions with FDA
Assists with preparations for FDA and Advisory meetings
Provides clients with an ‘FDA style’ review of submissions
Advises on regulatory options and potential pathways
Helps clients make informed business decisions
Provides professionals to perform comprehensive due diligence reviews
Serves Venture Capitalists, M&A Parties and their Advisors, Industry Venture Groups, Business Development Departments, Alliances and Co-Development Partnerships
evaluates and provides guidance on all aspects of regulatory strategy for product development, such as: Orphan Drugs Designation, Fast Track, Break-through Therapy, Accelerated Approval, ANDA and 505(b)(2) submissions
Provides Nonclinical pharmacology and toxicology support for drugs and biologics
Provides Nonclinical program review and strategic support for pre-IND/IND engagements with the FDA
Provides strategy and guidance for NDA and BLA efforts, including FDA meeting requests, briefing packages, preparation, meeting attendance, and preparation of the clinical and CMC modules
MEDICAL DEVICE SUPPORT
Prepares or assists in the preparation of regulatory submissions for medical devices, including 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs
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