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Clinical Trial Regulatory Services
Applications when everything must go right.
Our Clinical Trial Regulatory Services team can help facilitate a seamless experience no matter where in the world you operate. By combining centralized data management with the ability to simultaneously manage multiple regulatory submissions, we can guide you through quicker trial start-up and follow-through.
We are also proud to ease your journey with labelling services in a single location. So whether you need a single label or a full library, we can work it into your full-service clinical trial management solution.
Partner for greater flexibility
Across your clinical development journey, consider our Clinical Trial Regulatory Services a hub for all. Whether you, a third party, or Parexel are managing your clinical trial, our processes and solutions are designed to bring everyone together. From your submission plan, assembly, and application management through delivery to master archiving, you’ll rest easy knowing all your assets are being managed by a single watchful team.
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What To Consider When Mapping Your Strategy For Submitting An Application To The National Drug Administration of China
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New post-market Surveillance requirements (PMS) for medical device manufacturers
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FDA Releases Draft Guidance on CMC for Gene Therapies
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Will You “Lose” On The FDAs 15 Day 483 Diet Plan?
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FDA Releases a Biopharmaceutical Naming Update
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SEE FULL CONTENT STREAM
What To Consider When Mapping Your Strategy For Submitting An Application To The National Drug Administration of China
Read Now
New post-market Surveillance requirements (PMS) for medical device manufacturers
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FDA Releases Draft Guidance on CMC for Gene Therapies
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Will You “Lose” On The FDAs 15 Day 483 Diet Plan?
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FDA Releases a Biopharmaceutical Naming Update
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New Zealand Draft Therapeutics Product Bill: Are You Prepared?
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CMC readiness remains the major hurdle when conducting cell and gene therapy trials
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The State of Germline Gene Editing. What We Don’t Know!
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FDA Publishes Guidances Aimed at More Inclusive Eligibility Criteria for Cancer Clinical Trials
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Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules
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Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?
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How New India Clinical Trial Regulations Will Improve Drug Development
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Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products
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Falsified medicine directive EU
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Good Tissue Practices (GTP): A Lesser-Known GxP
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Regulatory Pathway for New Drug Importation into China
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Leverage regulatory reform in China, but mitigate the risks
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FDA Compliance: When Does Electronic Data become a cGMP Record?
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Qualification as a Step Toward Assay Validation for CBER Regulated Cell and Gene Therapy Products
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A Guide to a No Deal BREXIT
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How to Successfully Obtain Breakthrough Device Designation
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A Harmonized Approach to Data Integrity
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Points to Consider for Manufacturing Biologics at the Clinical Site
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Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products
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Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations
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FDA Accelerates Initiatives to Modernize and Strengthen 510(k) Program
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FDA Publishes Draft Guidance - Labeling for Human Prescription Drug and Biological Products
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FDA Publishes Draft Guidance- Rare Diseases: Common Issues in Drug Development
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Gene Therapy, the Cure and the Reality
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Points to Consider for Establishing Biotechnological/Biological Product Comparability
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Points to Consider When Mitigating Biopharmaceutical Virus Risk
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Points to Consider When Designing a Biologics Manufacturing Facility, Planning for Success Early On!
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FDA Compliance Deadline for Stem Cell Clinics Offering Unapproved Products to Public
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How to Right-Size Quality and CGMP Compliance Investments
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A Perspective on GMPs for Cellular Therapy Commercialization
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Four trends that could shape the future of advanced therapy products
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One step closer to a refined US Biosimilar Landscape
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Join Us At RAPS - Booth #339 in Vancouver, BC - Oct 1st and 2nd
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NDA To BLA Conversion-Are You Ready?
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MHLW Announces Deadline for Submitting “SAKIGAKE” Designation
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“No Deal” Brexit preparation from UK regulator MHRA
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FDA Pregnancy Risk Categories: Old and New – What do we need to know?
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The New Approval Pathway for Generic Drugs: Competitive Generic Therapy
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FDA Guidance for Industry: ANDA Submissions
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Brazil Priority Review Update
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FDA Publishes Liposome Drug Products Guidance
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A Practical Guide to Generic Medicines in Europe
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The Integrity of Electronic Data in Clinical Studies
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Consider Clinically Relevant Novel Endpoint at Earlier Disease Stage To Change Outcome of More Patients
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Adding A Simple Audit Trail Function To Excel
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Avoid Approval Delays! FDA’s New Draft Good ANDA Submissions Guidance provides a “Must-Have List” of Common Deficiencies
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A Practical Guide to Quality by Design (QbD) for Pharmaceutical Product Development
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Accelerated Pathways And The Agency Readiness Of Your Facilities
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EMA Updated First-in-Human Guidance Effective February, 2018
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PAREXEL’s Resounding Response to FDA’s Observation Trends
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FDA Revises Surveillance Inspection Program, Implements New Communication Timelines, and Clarifies Roles and Responsibilities
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ICH Q12 to Step 2, Regional Publication to Follow
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Regulatory & Commercial Guidance on PDUFA VI: Interpretation, Strategy & Implementation
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FDA Releases Long-Awaited Guidance on 3-D Printed Products
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