Regulatory Sciences

Expertise in Strategic Drug and Device Development for Optimal Market Outcomes.

ATI Life Science Staffing

World-Class Regulatory Science Consultancy

ATI Life Science Staffing provides comprehensive regulatory consulting services for pharmaceutical, biotech, and medical device companies. Our focus is on streamlining regulatory processes to achieve your business goals efficiently. Our team offers unparalleled expertise in US and European regulatory frameworks. We specialize in creating detailed product strategies, guiding you through critical milestones, and ensuring successful outcomes for submissions, meetings, and post-authorization operations.

Regulatory Operations

Our Regulatory Operations services streamline the marketing authorization application process, ensuring timely submissions and compliance with regional regulatory requirements. We support dossier compilation, submission management, and interactions with health authorities.

Submissions & Applications

ATI Life Science Staffing offers expert guidance and support for regulatory submissions throughout your product’s development and launch phases. We handle a variety of submissions, including IND, NDA, ANDA, ODD, BLA, IDE, 510(K), and PMA in the US, and provide support for Scientific Advice meetings, PIPs, ODDs, MAAs, and CE filings in Europe.

IND & NDA Submission Guidance

Our consultants assist with IND and NDA submissions, ensuring error-free applications that include comprehensive information on pharmacology, toxicology, manufacturing, and clinical trial protocols. We help determine the appropriate regulatory pathway for NDA submissions (505(b)(1) or 505(b)(2)) and provide end-to-end guidance through the submission process.

ANDA Consulting Expertise

We offer comprehensive support for ANDA submissions, ensuring your generic drug products demonstrate bioequivalence to Reference Listed Drugs and meet all FDA requirements. Our services include developing submission strategies, compiling applications, and ensuring compliance with FDA standards.

Orphan Drug Designation & BLA Support

ATI Life Science Staffing aids in obtaining orphan designation and BLA approvals. We evaluate product eligibility, prepare and submit applications, and provide strategic guidance for BLA submissions, including planning and execution.

Regulatory Authority Meeting Preparation

Our team provides meticulous preparation and support for regulatory authority meetings, including Pre-IND, End of Phase 2, and FDA Advisory Committee meetings. We ensure your interactions with health authorities are well-planned and executed, focusing on strategic communication and alignment with regulatory requirements.

Regulatory CMC Consulting

We offer Chemistry, Manufacturing, and Controls (CMC) consulting, ensuring your product meets quality standards and regulatory compliance throughout its lifecycle. Our services include developing CMC strategies, advising on manufacturing processes, and ensuring robust documentation.

Advertising & Promotional Review

ATI Life Science Staffing excels in Advertising and Promotional Review services, helping clients develop compliant marketing materials while maintaining brand growth. Our services include medical and regulatory review, marketing operations, and promotional material submission.

Global Labeling Services

We provide expert global label services, assisting with strategy development, lifecycle management, and regulatory negotiations for a range of products. Our team ensures accurate, compliant labeling for successful market entry and sustained market presence.

Market Access & Reimbursement Strategy

ATI Life Science Staffing specializes in Market Access and Reimbursement strategies for therapeutics and medical devices. We deliver customized solutions to ensure successful market entry, expansion, and patient access, integrating market and regulatory insights for optimal outcomes.

ATI Life Science Staffing offers a comprehensive suite of regulatory science services, ensuring your pharmaceutical, biotech, or medical device product navigates the complex regulatory landscape successfully. From initial submissions to market access strategies, our team is dedicated to supporting your product’s journey to market, maintaining compliance, and achieving commercial success.

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Elevate your staffing experience with ATI Life Science Staffing. Contact us now to experience excellence in Life Sciences staffing, where precision meets passion, and success is the ultimate destination.

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