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+1 617 454 9300
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+1 919 544 3170
© 2000-2021. Parexel International Corporation.
Regulatory Consulting
Start your regulatory journey on the right foot.
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:
- Regulatory Strategy & Development Planning
- Regulatory / GMP Compliance
- Regulatory Partnerships
- Clinical Trial Regulatory Services
Meet Our People
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.
Video: Beginning with the end in mind
Understand how Parexel's Regulatory Services can help you navigate regulatory complexities
Meet our experts
Our 1000+ consulting team includes ~100 former regulators, HTA assessors and inspectors.
Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?
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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 for Establishing Biotechnological/Biological Product Comparability
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Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products
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FDA & EMA Joint Report on Early Access Pathways
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A Long and Winding Road for Transdermal Products – FDA Has It Covered
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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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Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications
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Rescuing Product Approvals from Data Integrity Issues
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Biosimilars in China
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SEE FULL CONTENT STREAM
Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?
Read Now
Points to Consider When Referencing a Master File in FDA Regulatory Submissions (IND, BLA, NDA)
Read Now
Points to Consider for Establishing Biotechnological/Biological Product Comparability
Read Now
Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products
Read Now
FDA & EMA Joint Report on Early Access Pathways
Read Now
A Long and Winding Road for Transdermal Products – FDA Has It Covered
Read Now
Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring
Read Now
Facilities and the 356h Form - Ensuring All Relevant Manufacturing Establishments are Appropriately Identified in FDA Drug Applications
Read Now
Rescuing Product Approvals from Data Integrity Issues
Read Now
Biosimilars in China
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Commercializing Gene and Cellular Therapy
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Impact of MDR, Article 117 medicinal products with an integral medical device
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Critical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine
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New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers
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Tips from FDA – Put Design of Experiments to Use in Drug Applications
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Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products
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What you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry
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Further Limits on The Use of Guidance for Enforcement – How Will FDA React?
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Can FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?
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What FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products
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Advice for Handling Potentially Mutagenic Impurities in Regulatory Submissions
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PAI Objectives Remain the Same, However Important Updates are Included
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When There Is No Guidance – Navigating Regulatory Meetings With FDA
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Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance
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All EU Members Have Now Joined!
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RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform
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Former FDA expert provides valuable advice on INTERACT programs for CBER products
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English Requirement for FDA GMP Documents
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Bispecific Antibody Development Program Guidance
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Key Questions to Consider When Licensing Cell & Gene Therapy Products
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The State of Germline Gene Editing. What We Don’t Know!
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Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products
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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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Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules
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Regulatory Pathway for New Drug Importation into China
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Good Tissue Practices (GTP): A Lesser-Known GxP
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FDA Compliance: When Does Electronic Data become a cGMP Record?
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New Zealand Draft Therapeutics Product Bill: Are You Prepared?
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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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Falsified medicine directive EU
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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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FDA Accelerates Initiatives to Modernize and Strengthen 510(k) Program
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Points to Consider for Manufacturing Biologics at the Clinical Site
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FDA Publishes Draft Guidance - Labeling for Human Prescription Drug and Biological Products
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Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations
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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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Leverage regulatory reform in China, but mitigate the risks
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Points to Consider When Designing a Biologics Manufacturing Facility, Planning for Success Early On!
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FDA Publishes Draft Noncirrhotic Non-alcoholic Steatohepatitis (NASH) With Liver Fibrosis Guidance
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FDA Compliance Deadline for Stem Cell Clinics Offering Unapproved Products to Public
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Navigating the recent FDA Guidances for Industry: Generic Drugs and Shared System REMS
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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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MHLW Announces Deadline for Submitting “SAKIGAKE” Designation
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We are always available for a conversation.