8 Federal Street, Billerica, MA 01821
+1 978 313 3900
2520 Meridian Parkway,
Research Triangle Park, Suite 200,
Durham, NC 27713
+1 919 544 3170
© 2000-2019. Parexel International Corporation.
8 Federal Street, Billerica, MA 01821
+1 978 313 3900
2520 Meridian Parkway,
Research Triangle Park, Suite 200,
Durham, NC 27713
+1 919 544 3170
© 2000-2019. Parexel International Corporation.
Trust is your most valuable asset. That’s why our Risk Mitigation and Regulatory Compliance Management team is ready to help you establish trust with regulatory agencies or build it back up again after an issue. Because many of our advisors are former FDA, EMA, and NMPA regulators, we can guide you through sensitive remediation and data integrity audits. And should your biopharmaceutical or medical device operation go global, we can set you up with proactive strategies to build trust along the way.
Additionally, our knowledgeable Agency Readiness Services team helps you submit high-quality dossiers on time and ensures cGMP-compliant facilities are used to gain regulatory success.
A new report by the Economist Intelligence Unit (EIU) and commissioned by Parexel reveals that new innovations in drug development have a positive impact on clinical trial timelines, likelihood of market launch, and inclusion on selected payer formularies.
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
Read Now
FDA Releases Draft Guidance on CMC for Gene Therapies
Read Now
Will You “Lose” On The FDAs 15 Day 483 Diet Plan?
Read Now
FDA Releases a Biopharmaceutical Naming Update
Read Now
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
Read Now
FDA Releases Draft Guidance on CMC for Gene Therapies
Read Now
Will You “Lose” On The FDAs 15 Day 483 Diet Plan?
Read Now
FDA Releases a Biopharmaceutical Naming Update
Read Now
New Zealand Draft Therapeutics Product Bill: Are You Prepared?
Read Now
CMC readiness remains the major hurdle when conducting cell and gene therapy trials
Read Now
The State of Germline Gene Editing. What We Don’t Know!
Read Now
FDA Publishes Guidances Aimed at More Inclusive Eligibility Criteria for Cancer Clinical Trials
Read Now
Four Strategies for Capitalizing on China’s New Generic Drug “4+7” Bulk-Buying Rules
Read Now
Root Cause: Why does Regulatory Approval Not Always Equate to Commercial Success?
Read Now
How New India Clinical Trial Regulations Will Improve Drug Development
Read Now
Q&A: Developing and Labeling of In-vitro Companion Diagnostic Devices for Oncology Products
Read Now
Falsified medicine directive EU
Read Now
Good Tissue Practices (GTP): A Lesser-Known GxP
Read Now
Regulatory Pathway for New Drug Importation into China
Read Now
Leverage regulatory reform in China, but mitigate the risks
Read Now
FDA Publishes Draft Noncirrhotic Non-alcoholic Steatohepatitis (NASH) With Liver Fibrosis Guidance
Read Now
FDA Compliance: When Does Electronic Data become a cGMP Record?
Read Now
Regenerative Medicine versus Regenerative Medicine Therapies versus Regenerative Advanced Therapy, What is the Difference?
Read Now
Qualification as a Step Toward Assay Validation for CBER Regulated Cell and Gene Therapy Products
Read Now
A Guide to a No Deal BREXIT
Read Now
How to Successfully Obtain Breakthrough Device Designation
Read Now
A Harmonized Approach to Data Integrity
Read Now
Points to Consider for Manufacturing Biologics at the Clinical Site
Read Now
Benefits of Identifying Critical Quality Attributes, and Correlating the CQAs with Clinical Outcomes for Biologic Products
Read Now
Updates on Regenerative Medicine Advanced Therapy (RMAT) Designations
Read Now
FDA Accelerates Initiatives to Modernize and Strengthen 510(k) Program
Read Now
FDA Publishes Draft Guidance - Labeling for Human Prescription Drug and Biological Products
Read Now
FDA Publishes Draft Guidance- Rare Diseases: Common Issues in Drug Development
Read Now
Gene Therapy, the Cure and the Reality
Read Now
Points to Consider for Establishing Biotechnological/Biological Product Comparability
Read Now
Points to Consider When Mitigating Biopharmaceutical Virus Risk
Read Now
Points to Consider When Designing a Biologics Manufacturing Facility, Planning for Success Early On!
Read Now
FDA Compliance Deadline for Stem Cell Clinics Offering Unapproved Products to Public
Read Now
Points to Consider When Referencing a Master File in FDA Regulatory Submissions (IND, BLA, NDA)
Read Now
Navigating the recent FDA Guidances for Industry: Generic Drugs and Shared System REMS
Read Now
How to Right-Size Quality and CGMP Compliance Investments
Read Now
A Perspective on GMPs for Cellular Therapy Commercialization
Read Now
Four trends that could shape the future of advanced therapy products
Read Now
One step closer to a refined US Biosimilar Landscape
Read Now
Join Us At RAPS - Booth #339 in Vancouver, BC - Oct 1st and 2nd
Read Now
NDA To BLA Conversion-Are You Ready?
Read Now
MHLW Announces Deadline for Submitting “SAKIGAKE” Designation
Read Now
“No Deal” Brexit preparation from UK regulator MHRA
Read Now
FDA Pregnancy Risk Categories: Old and New – What do we need to know?
Read Now
The New Approval Pathway for Generic Drugs: Competitive Generic Therapy
Read Now
FDA Guidance for Industry: ANDA Submissions
Read Now
Are you an OTC manufacturer that has never been inspected by the FDA? - Are you prepared?
Read Now
FDA Publishes Q&A Document on ICH Q7
Read Now
Innovative Approaches for Advancing Precision Medicine Development
Read Now
FDA Publishes Q&A Document on ICH Q11
Read Now
Brazil Priority Review Update
Read Now
FDA Publishes Liposome Drug Products Guidance
Read Now
A Practical Guide to Generic Medicines in Europe
Read Now
The Integrity of Electronic Data in Clinical Studies
Read Now
Consider Clinically Relevant Novel Endpoint at Earlier Disease Stage To Change Outcome of More Patients
Read Now
Adding A Simple Audit Trail Function To Excel
Read Now
Avoid Approval Delays! FDA’s New Draft Good ANDA Submissions Guidance provides a “Must-Have List” of Common Deficiencies
Read Now
A Practical Guide to Quality by Design (QbD) for Pharmaceutical Product Development
Read Now
Accelerated Pathways And The Agency Readiness Of Your Facilities
Read Now
EMA Updated First-in-Human Guidance Effective February, 2018
Read Now
PAREXEL’s Resounding Response to FDA’s Observation Trends
Read Now
FDA Revises Surveillance Inspection Program, Implements New Communication Timelines, and Clarifies Roles and Responsibilities
Read Now
ICH Q12 to Step 2, Regional Publication to Follow
Read Now
Regulatory & Commercial Guidance on PDUFA VI: Interpretation, Strategy & Implementation
Read Now
FDA Releases Long-Awaited Guidance on 3-D Printed Products
Read Now