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Global Regulatory Affairs

Home / Global Regulatory Affairs
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Global Regulatory Affairs

Home / Global Regulatory Affairs
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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.

GRA Strategic Regulatory Planning
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

GRA Correspondence with regulatory Agencies Final
Requests from Regulatory Agencies
Requests for engagement or feedback are initiated via a briefing document that describes product development. QPS can facilitate and author this briefing document based on your product specifications.
Pre-submission Meetings
Preparation of pre-submission meetings for global Health Authorities

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

Regulatory Feedback Meetings
QPS offers agency meeting preparation services and meeting debriefing opportunities. QPS can also help clients connect with regulatory agencies for ongoing planning.

Preparation of meeting minutes I  Support in implementing action items post Health Authority engagement I Regulatory mitigation plans, if deficiencies have been identified

GRA Authoring
Regulatory Documentation Support
QPS can author, review, and publish product lifecycle regulatory filings, including annual reports, supplements, and safety reporting.

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

GRA Lifecycle Management
Regulatory Support Throughout Product Lifecycle
QPS supports drug development product lifecycle regulatory filings across the continuum of required discussions.

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

GRA Expedited Programs
Expedited Program Support
QPS specializes in expedited programs for products showing early signs of efficacy for unmet medical needs. Additionally, our experts can facilitate interactions with the regulatory agencies associated with expedited programs.

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. 

CTIS Timeline Infographic

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.

Links to Relevant Documents

  • Understanding And Navigating Changes To Clinical Trial Management In The European Union
  • EU Clinical Trial Regulation 536/2014 and CTIS: Common Questions and Answers
  • Navigating Changes to EU Clinical Trial Management: What You Need to Know
  • Global Medical & Regulatory Affairs

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Time is of the essence in Drug Development.

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  • Mission, Vision, and Values
  • QPS History
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  • Assay Finder
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Clinical Services

  • Early Phase Clinical Trials
  • Leukopak Services
  • Global Medical Affairs
  • Global Regulatory Affairs
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  • Early Phase Clinical Trials
  • Leukopak Services
  • Global Medical Affairs
  • Global Regulatory Affairs
  • Therapeutic Areas

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