275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
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+1 919 544 3170
© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
The final stretch of regulatory submissions can seem murky – especially when that path takes you through the requirements of multiple countries. Every one of our 1000+ regulatory consultants across 110 countries share a deep understanding of intricate regulatory requirements and a sense of urgency to get important therapies to those who need them. In fact, many of them are former regulators themselves.
Working together, our regulatory consulting services empower you to maintain control of your pathway and stay ahead of any compliance risks. With practical interpretation, we help you understand how guidelines around the world apply to you – including in expanding markets like China.
Our services include:
With Parexel, a seasoned advisor is always close by and ready to guide your molecule to market, including strategic compliance experts and former FDA, EMA and NMPA employees. Click to meet some of our team.
Understand how Parexel's Regulatory Services can help you navigate regulatory complexities
Our 1000+ consulting team includes ~100 former regulators, HTA assessors and inspectors.
When There Is No Guidance – Navigating Regulatory Meetings With FDA
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Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations
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Tips from FDA – Put Design of Experiments to Use in Drug Applications
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The State of Germline Gene Editing. What We Don’t Know!
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Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?
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RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data
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RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform
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Rescuing Product Approvals from Data Integrity Issues
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Browse the Parexel Resource Center for our latest content on clinical trial supplies, logistics, innovation, drug safety, cell & gene therapy, and more!
When There Is No Guidance – Navigating Regulatory Meetings With FDA
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What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry
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What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products
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Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations
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Tips from FDA – Put Design of Experiments to Use in Drug Applications
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The State of Germline Gene Editing. What We Don’t Know!
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Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?
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RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data
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RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform
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Rescuing Product Approvals from Data Integrity Issues
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Regulatory Pathway for New Drug Importation into China
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Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?
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Qualification as a Step Toward Assay Validation for CBER Regulated Cell and Gene Therapy Products
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Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products
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Points to Consider When Referencing a Master File in FDA Regulatory Submissions (IND, BLA, NDA)
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Points to Consider When Designing a Biologics Manufacturing Facility, Planning for Success Early On!
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Points to Consider When Mitigating Biopharmaceutical Virus Risk
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Points to Consider for Establishing Biotechnological/Biological Product Comparability
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Points to Consider for Manufacturing Biologics at the Clinical Site
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PAI Objectives Remain the Same, However Important Updates are Included
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One step closer to a refined US Biosimilar Landscape
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New Zealand Draft Therapeutics Product Bill: Are You Prepared?
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New Zealand Consultation on Proposed Warning Statements for Allergens in Medicines
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New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers
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Navigating the recent FDA Guidances for Industry: Generic Drugs and Shared System REMS
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MHLW Announces Deadline for Submitting “SAKIGAKE” Designation
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Leverage regulatory reform in China, but mitigate the risks
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Key Questions to Consider When Licensing Cell & Gene Therapy Products
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Join Us At RAPS - Booth #339 in Vancouver, BC - Oct 1st and 2nd
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Impact of MDR, Article 117 medicinal products with an integral medical device
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How to Successfully Obtain Breakthrough Device Designation
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How to Right-Size Quality and CGMP Compliance Investments
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How New India Clinical Trial Regulations Will Improve Drug Development
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Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance
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Good Tissue Practices (GTP): A Lesser-Known GxP
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Gene Therapy, the Cure and the Reality
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Further Limits on The Use of Guidance for Enforcement – How Will FDA React?
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Four trends that could shape the future of advanced therapy products
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Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules
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Former FDA expert provides valuable advice on INTERACT programs for CBER products
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FDA & EMA Joint Report on Early Access Pathways
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FDA Compliance Deadline for Stem Cell Clinics Offering Unapproved Products to Public
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FDA Compliance: When Does Electronic Data become a cGMP Record?
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FDA Accelerates Initiatives to Modernize and Strengthen 510(k) Program
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Falsified medicine directive EU
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Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications
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English Requirement for FDA GMP Documents
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Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring
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Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products
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Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine
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Commercializing Gene and Cellular Therapy
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CBER Launches CATT to Facilitate Innovation
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Can FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?
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Bispecific Antibody Development Program Guidance
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Biosimilars in China
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Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products
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All EU Members Have Now Joined!
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Advice for Handling Potentially Mutagenic Impurities in Regulatory Submissions
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A Perspective on GMPs for Cellular Therapy Commercialization
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