Global Regulatory Affairs
QPS offers extensive Global Regulatory Affairs (GRA) services, which allow pharmaceutical, biotechnology, and medical device companies to develop custom-built research solutions in compliance with regulatory agencies worldwide. Our expertise encompasses discovery, preclinical, clinical, and commercial regulatory services to bring new technologies to patients faster.
Why You Need a Global Regulatory Affairs Partner
Experience is key when guiding drug development through the regulatory process. With that in mind, QPS offers a full suite of GRA services to drive innovative asset development, along with external and internal stakeholder engagement, driving our clients toward precise, groundbreaking research outcomes.
As a GRA team, we are known for our deep, global regulatory knowledge. Our team of professionals has deep expertise in the varied and nuanced rules and regulations tied to drug development programs around the world. At QPS, we offer partnerships to meet individual client needs throughout the development lifecycle, providing strong support and a range of capabilities to ensure your regulatory interactions, discussions, and documents are comprehensive and cohesive, driving toward the success of your product development initiatives.
Our custom-built global regulatory programs and solutions are designed to ensure your asset development and external stakeholder management are second to none.
The Importance of Regulatory Planning
The Global Regulatory Affairs (GRA) framework encompasses the regulations set forth by regulatory bodies worldwide. The framework’s primary goal is to safeguard public health by overseeing the development, manufacturing, and distribution of medical testing products while ensuring compliance with applicable standards.
The Global Regulatory Affairs Process
US FDA – Type A, B, C meetings I BPD meetings for biosimilars I pre-ANDA meetings for complex generics I EMA – scientific meetings I EMA pre-submission meetings I pre-CTA meetings I NMC meetings
Preparation of meeting minutes I Support in implementing action items post Health Authority engagement I Regulatory mitigation plans, if deficiencies have been identified
Global first-in-human applications I Ongoing safety reporting I Global marketing applications I Supplements and annual reports I eCTD documents (electronic publication and submission) I Inspectional Readiness Program
Annual reports I Supplements I Safety reporting I Import/export regulatory documentation I Rolling product review applications I Post-approval commitments planning and implementation I CMC lifecycle management I Annual registrations and listings I Regulatory assessment of supporting documents to support and plan for submission of renewal applications
Orphan drug applications I INTERACT I Regenerative Medicine Advance Therapy (RMAT) I Breakthrough I Fast Track I PRIME I Sakigake
QPS Global Regulatory Affairs Planning Phases
QPS can work with you to navigate the complex Global Regulatory Affairs framework, ensuring your product’s compliance and efficiency en route to global market access. For support with your GRA needs, contact our experts today.
Strategic, Preclinical Regulatory Planning
- Expedited Programs such as INTERACT, Regenerative Medicine Advance Therapy (RMAT), Breakthrough, Fast Track, PRIME, and Sakigake
- Investigational New Drug (IND)
- Clinical Trial Application (CTA)
- Investigational Medicinal Product Dossier (IMPD)
- eCTD publishing
Late Phase (Phase IIb-IV) Clinical Regulatory Services
- Annual reports and supplements
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Safety reporting
- Global Electronic Common Technical Document (eCTD) publishing
- Inspectional Readiness Program
- Accelerated approval
Early Phase (Phase I-IIa) Clinical Regulatory Services
- Rolling submission
- Accelerated programs
- Annual reports
- Supplements
- Safety reporting
- Regulatory briefing documents and communications
Post-approval/ and Commercial Phase Regulatory Services
- Annual reports and supplements
- Periodic Adverse Drug Experience Report (PADER), Periodic Adverse Experience Report (PAER), and Periodic Safety Update Report (PSUR)
- Pharmacovigilance
- Inspection findings commitments and responses
Clinical Trials Information System
The sponsor workspace in the Clinical Trials Information System (CTIS) assists clinical trial sponsors and other organizations running clinical trials in the European Union to prepare and compile clinical trial applications and dossiers for submission and assessment by Member States in the European Union (EU). As of January 31, 2022, the Clinical Trials Information System (CTIS) became the single-entry portal for submitting clinical trials information in the EU, supporting the day-to-day business processes of authorities and sponsors throughout the life cycle of a clinical trial.
Implementation of the EU Clinical Trial Regulation 536/2014
- Redaction and deferral strategy and support
- Project management
- Upload of Part 1 and Part 2 documentation into CTIS
- Compiling, validation, and substantial modification management
- Gap analysis of existing documentation to regulatory requirements
- Training on CTIS and drafting of supporting CTIS SOPs
Time is of the essence in 2024, as the deadline for sponsors to have all active clinical trials listed in CTIS is January 2025. The QPS Global Regulatory Affairs team is well-equipped to handle this transition for you.
Our team cares about your individual program needs, and we are dedicated to forming a strategic partnership to elevate your development strategy. Our team of experienced scientists, physicians, and clinical research professionals has deep expertise in clinical study design, asset development strategy, study conduct, medical management, and safety oversight. Contact us today and we will set up a meeting to get started.
