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Regulatory & Compliance
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Regulatory Affairs

Madison Technical is the world leader in providing specialized and highly qualified regulatory specialists who have the experience and training to bring a product quickly to market.

Madison Technical consultants work closely with you on all phases of your project from concept design to approval and implementation. We not only assist in building a successful project, but can identify and recommend alternative solutions that save our clients time and money.

Our expertise encompasses design, manufacturing, computerized systems, and quality assurance and regulatory compliance within the life sciences industry. Our experienced consultants can assist you in identifying and resolving obstacles quickly.

Madison Technical consultants have the in-depth knowledge and experience to help you resolve issues relating to IND, NDA, BLA, ANDA, Pre Approval Inspections (PAI), IDE, 510K, PMA and FDA Registered Agent Services.

Our regulatory affairs consultants have the skills and experience in ensuring that medical device manufacturers, healthcare organizations, and companies in the pharmaceutical industry comply with government regulations and laws relevant to the client’s products. This would include the ability to:

• Prepare, review and assemble document submissions to global regulatory authorities, including new applications, registration, renewals, product listings and investigational applications.
• Coordinate with relevant agencies to resolve issues and speed up approvals.
• Setup and implement regulatory standard operating procedures.
• Handle day-to-day regulatory operations.
• Provide expert advice on regulatory strategy.

Our regulatory affairs consultants should have the necessary skills to provide the following services to our clients:

• Post Approval Reports
• Biologics License Application (BLA) Submissions
• Regulatory Agency Interaction
• Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs
• Drug Master Files (DMFs)
• NDA/ANDA Submissions

Madison Technical has a worldwide presence with clients in 23 countries and offices in the U.S., Puerto Rico, Europe, and Asia. We are the world’s largest specialized technical staffing company.

Madison Technical consulting teams are serving clients around the globe. Our skilled experts are ready to go to work for you anywhere-anytime.

Let us show you why partnering with the global leader in specialized technical staffing services is the right choice for your company.

Contact Madison Technical today to learn how we can help you.

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(800) 206-7956