Resources

Case Studies

Drug Supply Chain

US Drug Supply Chain Security Act (DSCSA): How Medical Device Manufacturers Must Comply

Planning ahead for unexpected regulatory implications down the road.

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Magnifying Glass Due Diligence

Internal Due Diligence

Understanding Your Company’s Shortfalls before Others Find Them

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Pills and Growth Chart

Commercial Readiness

How Priorities Must Shift to Launch Your First Commercial Product

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Nurse with Patient

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.

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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.

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Media

E-BOOK: Six Expert Tips to Succeed as an Emerging Biotech Company

Emerging Biopharma and Biotech drive the majority of trials and innovation in life sciences. However, they are restricted by lean resources, limited access to sites and patients, lack of integrated systems, and risk of uncertain funding. How can emerging biotech companies stay ahead of other segments and still succeed? This eBook summarizes and compiles learnings as expert tips to help power the decisions that will accelerate your study’s success. DOWNLOAD

PODCAST: Usability & Human Factor with Sharon Ayd

Medical Device Made Easy, August 19, 2019

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

All clinical trials come with their own set of unique complexities. You need a CRO partner that can help guide you through these challenges, especially during the critical early study phases. Registration required. WATCH NOW

Published Articles & Interviews

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

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