Therapeutic Products, Regulatory and Quality Services in UNITED STATES

The Food and Drug Administration (FDA, referred as The Agency) regulatory process can seem like a maze whether your company is a multinational with extensive regulatory experience or a company that is newly emerging in the marketplace. MEDERA helps you navigate this maze by tailoring our strategic regulatory solutions to your needs. MEDERA Consultants have over 15 years of experience in U.S. Regulatory Affairs and obtaining a full range of regulatory approvals for our clients.

Our initial meetings and conversations with clients are used to develop regulatory strategies for a specific project. Our goal is to develop a regulatory strategy that meets both client needs and U.S. regulatory requirements. We then work with the client to implement these strategies.

MEDERA offers a full range of consulting solutions to facilitate US registration of your specific product(s). MEDERA can handle the entire registration process from submission preparation through to managing the review process with FDA. We can also review submissions prepared by your staff to provide a critical review with the goal of identifying deficiencies so that FDA’s review is more streamlined.

The Food and Drugs Act (FDA) provides the regulatory framework for the registration and sale of therapeutic products in U.S. MEDERA handle all aspects of compliance with the FDA from product registrations through to approvals and then post-approval changes.

MEDERA can provide a Free Assessment of how these regulations apply to your particular product. Simply contact us to provide information about your products. Click here to find out more about our regulatory consulting services or to receive a free copy of our white paper on marketing a therapeutic product in US.