Pharmaceutical Regulatory Compliance

INSIGHTS ON REGULATORY COMPLIANCE

Viral Gene Therapy: Reducing Costs To Improve Patient Access
Gene therapy is revolutionizing medicine with its potential to cure genetic disorders. As approvals rise, so do concerns about accessibility, with million-dollar price tags limiting patient access.
Integrated Approach In Managing CPV And APQR
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
Validation Of A Sterilization Process: Part 1
Gain essential insights into sterilization by exploring microbial inactivation kinetics, bacterial spore resistance, and key terminology—critical knowledge for ensuring product safety and compliance.
MilliporeSigma Bio-Expo Live February 2025: Upstream Bioprocessing
Review the benefits of implementing a closed and sterile sampling system, such as NovaSeptum®, to improve sampling procedures and meet regulatory expectations.

Indian Biosimilar Companies Are Poised To Succeed In The Global Market
3/31/2025

For Indian biosimilar developers looking to capitalize on the upcoming patent cliff, it is vital to play to your strengths and identify strategies for breaking into competitive regulatory markets.
Adapt Or Fail: The Urgency Of Pandemic Preparedness For Sterile Injectable Manufacturing
5/12/2025

A successful large-scale public health emergency response requires adaptable manufacturing capabilities, an experienced workforce, and effective private-public partnerships.
Advances In Regulations For Viable Environmental Monitoring
2/21/2025

Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.
Sample Sizes For Performance Testing Of Combination Products, Packaging
5/16/2025

When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.
Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want?
12/5/2023

In this segment, Combined Therapeutics CSO Thomas Van Cott, Ph.D. and Omega Therapeutics Executive Director, Process Development and Analytical Sciences Jeff Atkinson, Ph.D. address regulators’ likely safety and CQA concerns as well as audience questions regarding variable and changing RNA constructs.

Commissioning, Qualification, Regulatory Compliance Services

We help you implement innovative approaches that help you achieve higher quality, increased reliability, faster project delivery, reduced energy and operating costs, and an integrated, business focused approach to regulatory compliance.
Medical Writing Software

Accelerate Medical Writing Without Compromising Accuracy or Compliance

In the fast-paced world of clinical research, the ability to produce, review, and finalize high-quality documents—on time and with full regulatory compliance—is non-negotiable. Ideagen Document Review (formerly known as PleaseReview) is the trusted collaboration and co-authoring platform that enables clinical teams to streamline document reviews, reduce version chaos, and ensure traceable, auditable feedback across the board.
Programming Simplicity And Operational Consistency At Your Fingertips

Streamline your lab automation with a customizable touchscreen, dynamic programming, and real-time monitoring to boost productivity, minimize errors, and integrate data across workflows.
Reliable. Confident. Environmental Monitoring.

Optimize cleanroom operations with innovative monitoring systems that provide real-time data, improve investigations, and support regulatory compliance for aseptic environments.
Regulated Document Review

Enables secure real-time document review, co-authoring, and redaction in order to shorten the document review process by up to 65%.