Pharmaceutical & Biotech
Industry

The pharmaceutical and biotech industry continues to flourish in the changing landscape of healthcare. Whether you focus on the discovery, development, or manufacturing of drugs and medications- we can connect you with leaders in your field to define best practices.

Pharmaceutical Conferences

LIFE SCIENCE REGULATORY INTELLIGENCE & STRATEGY CONFERENCE

Reducing Risk & Increasing Clearance Certainty through Insightful Regulatory Intelligence & Strategy for Supporting Innovative Study Design Teams to Secure Rapid Product Approval, Expand Indications and Maintain Compliance for Marketed Products
OCTOBER 18-19, 2018 | ALEXANDRIA, VA | SHERATON SUITES OLD TOWN ALEXANDRIA

4TH ANNUAL GLOBAL REGULATORY AFFAIRS CMC CONFERENCE

Ensuring Compliant Developmental and Postmarket CMC Operations through the Employment of Thorough Product Lifecycle Management Tactics, Attaining a Comprehensive Understanding of US and Global Regulatory Requirements through to Utilizing Streamlined Processes for Expedited Pathway Approvals
OCTOBER 29-30, 2018 | PHILADELPHIA, PA | DOUBLETREE BY HILTON HOTEL PHILADELPHIA AIRPORT

3RD ANNUAL DIETARY SUPPLEMENT: REGULATORY STRATEGY CONFERENCE

Alignment with evolving regulations including USDA National Bioengineered Food Disclosure Law, California’s Proposition 65, FDA quality standards & ongoing substantiation of claims highlighting the utilization of social media & influencers.
DECEMBER 3-4, 2018 | ALEXANDRIA, VA | EMBASSY SUITES BY HILTON ALEXANDRIA OLD TOWN

COMBINATION PRODUCTS REGULATION CONFERENCE

Defining the Primary Mode of Action as a Drug or Device to Determine FDA Jurisdiction, Ensuring Optimized Human Factors Study Design to Prove Safe Patient Use, while Maintaining Compliance With Post Market Reporting Requirements
FEBRUARY 28 – MARCH 1, 2019 | ARLINGTON, VA

Latest News from our Pharmaceutical Blog

Find What Works For You

Technology is always changing. From new cell phones that help you connect to rockets that go out in to the universe. Technology empowers people to be innovative and create the best results. Stability testing is no different

Data Integrity While Building Stability Testing Program

Many industries require discretion and integrity. Stability testing is no different. One of the hottest topics in the stability industry is data integrity. Although this is not a new concept, new guidances have been put in place from the FDA. Data integrity is the...

Understanding and Incorporating ICH E6(R2)

In November 2016, ICH published an addendum to its guidelines for clinical practice, prompting pharmaceutical companies to align current clinical quality procedures with a risk-based monitoring approach.

PBMs Hold the Key to Pharmaceutical Success

Recent debates surrounding drug pricing have forced the pharmaceutical industry to navigate multiple avenues ensuring optimal coverage while maintaining high levels of ROI. Though the industry has worked extensively with insurance providers, building positive...

Will 2018 be Pharma’s Greatest Year Yet?

Will 2018 be Pharma’s Greatest Year Yet?   The pharmaceutical industry has faced many changes in 2017. Legislative uncertainty, patient-centricity, and ransomware threats are just a few of the industry’s hurdles so far. Looking ahead, however, the industry may be...

Forecasting Legislation and Industry Changes in the Trump Administration

Forecasting Legislation and Industry Changes in the Trump Administration   With the recent passing of the American Health Care Act (AHCA) through the U.S. House of Representatives, many industry leaders are anticipating the possible changes the AHCA may bring....

Patient Centricity is Changing the Pharmaceutical Industry

How the Patient Centricity is Changing the Pharmaceutical Industry   Over the past few years, drug makers have partnered with patients to deliver better drugs, gain more feedback, and provide more information about their products. This renewed focus on patient...

What Pharma Can Learn from WannaCry

What Pharma Can Learn from WannaCry   Over the past two weeks, healthcare networks across the globe have been infiltrated and patient data has been locked. These attacks, which are all connected to WannaCry ransomware, have spurred a conversation about what ransomware...

Trends Impacting Market Access and Coverage

Trends Impacting Market Access & Coverage The key to a successful product launch and quality patient care is market access and coverage. Obtaining high forumlary coverage is crucial to ensuring patients' access to treatments and increases the likelihood of...

Navigating Software Updates in the Electronic Submission Process with Pfizer

In recent years, advancements in technology have enabled regulatory operations and affairs teams to develop electronic submissions, streamlining the application process.

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