Resources
Case Studies
US Drug Supply Chain Security Act (DSCSA): How Medical Device Manufacturers Must Comply
Internal Due Diligence
Commercial Readiness
Picking the Right CRO for You
For many companies, selecting a CRO can be a stressful task as it is important to find one that could be your partner throughout the clinical trial process. And given that the time from the start of human clinical testing until a drug is actually approved by regulatory authorities can be anywhere from 10 to 18 years, you could be in for a long-term relationship with a CRO.
WHITEPAPER
Resources for Sponsors and Investigators Involved in Rare Disease Drug Development and Families Living with Someone with a Rare Disease
Regulatory pathways, such as the EMA’s Orphan Designation, are aimed at encouraging companies to take on development of drugs for rare conditions by allowing them a period of market exclusivity. Regulators realize that for rare diseases, the risk-benefit balance should be different, because people have no existing treatment options.
WHITEPAPER
Serialization Implementation for DSCSA Compliance
Pharmaceutical LSPs operate at a critical point between manufacturers and dispensers in the pharmaceutical supply chain. Movement of critically important products depends on comprehensive regulations created and administered by government and other regulatory authorities. The DSCSA is the reason for sweeping changes throughout the industry. Companies should take a pro-active and strategic approach to assure compliance with DSCSA requirements.
SPEAKER SATURDAY
“How to Create Alliances to Accelerate Growth,” with Dr. Sharon Ayd.
Watch this video and learn how to use strategies that will help both executives and entrepreneurs scale their business opportunities.
Media
E-BOOK: Six Expert Tips to Succeed as an Emerging Biotech Company
PODCAST: Usability & Human Factor with Sharon Ayd
If you have some difficulty to understand the concept of Usability and Human Factor, this episode is perfect for you. We will not specifically talk about theory but really about practice with a case study. LISTEN
WEBINAR: The Importance of Picking the Right CRO
Published Articles & Interviews
Women Are Overmedicated Due to Male-Dominated Studies, Scientists Say
Giddy Magazine, September 16, 2021
Most drug research doesn’t analyze sex-specific data, which puts women at risk. READ MORE (login or registration required)
Impact of Non-Compliance on the American Healthcare Consumer
Pharmaceutical Technology, December 2, 2018
GMP non-compliance can spill over and impact patient access to life-saving medications. READ MORE
Ensuring the Quality of Biopharmaceuticals
BioPharm International, August 13, 2018
BioPharm International spoke with Sharon Ayd, founder & CEO of Ayd Biopharmaceutical Consulting Services, about what the future holds when it comes to ensuring quality in biopharmaceuticals. READ MORE
Responding to FDA CAPA Requests
Pharmaceutical Technology, July 2, 2018
BioPharm International spoke with Sharon Ayd, founder & CEO of Ayd Pharmaceutical Technology spoke with Sharon Ayd about developing a corrective action and preventive action (CAPA) plan. READ MORE
Managing the Cost of Non-Compliance
Pharmaceutical Technology, November 2, 2017
Creating a quality culture can prevent the costs and challenges associated with receiving a consent decree. READ MORE