pharm-fda-995x60 pharm-fda-995x60

FEATURED ARTICLES

  • Brexit’s Impact On The Global Pharmaceutical Industry: Market Authorization & Pricing
    Brexit’s Impact On The Global Pharmaceutical Industry: Market Authorization & Pricing

    The Brexit referendum has resulted in instability and uncertainty for many aspects of British society, including the pharmaceutical industry. As we discussed in Part 1 of this two-part article, life sciences funding and the common market are at risk, and with it billions of dollars in research funding and imports/exports. In this article, we will explore the UK’s future relationship with the EU after exit, which will affect many facets of the worldwide pharmaceutical industry, from marketing authorization to global pricing trends.

More Featured Articles

WHITE PAPERS & CASE STUDIES

More White Papers & Case Studies

PRODUCTS & SERVICES

NDA Approval And Post Approval Services NDA Approval And Post Approval Services

From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.

EZ BioPac™: Powder Transfer Process EZ BioPac™: Powder Transfer Process

Advanced Powder Transfer for Media and Buffer preparation and Solids additions.

Regulatory Services Regulatory Services

If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

Regulatory Regulatory

JHP Pharmaceuticals has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications, New Drug Submissions, and Supplements.

Adverse Event Reporting, Safety and Compliance Software Adverse Event Reporting, Safety and Compliance Software

Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.

LF-S BenchTop Single-Head Leak Testing Machine LF-S BenchTop Single-Head Leak Testing Machine

The Leak Testing Machine is used for off-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process on one Container at a time by means of a Testing Chamber under Vacuum or Pressure.

Drug Safety Issue Tracking Software Drug Safety Issue Tracking Software
Monitoring and tracking the efficiency and accuracy of organizations’ drug safety reporting process can help to ensure issues are logged and investigated when they arise, avoiding delays and/or inaccurate reporting which can result in lack of regulatory compliance, monetary fines, and unwanted scrutiny.
Drug Safety Software Adverse Event Reporting Drug Safety Software Adverse Event Reporting
TrackWise by Sparta Systems’ Adverse Event Reporting solution tracks reported adverse events and manages the processing of all cases from initial triage through reporting and case closure.
More Products & Services