Meranda Parascandola - DSI InPharmatics

May 13, 2023

Published by Meranda Parascandola at May 13, 2023

How to Identify Critical Process Parameters

Identifying critical process parameters (CPPs) is essential for ensuring the quality, safety and efficacy of pharmaceutical products. Critical process parameters are the key input variables that can affect the quality and consistency of a product. Failure to appropriately control these parameters can result in production failures, batch rejections and product […]

June 10, 2023

Published by Meranda Parascandola at June 10, 2023

Market Access: Implications of the Regional Convergence Trend on Biopharma and MedTech

On April 12, 2023, BeNeLuxA1 announced that negotiations failed to secure reimbursement for Libmeldy, a gene therapy developed by Orchard Therapeutics for the treatment of metachromatic leukodystrophy, on grounds of price. In the UK, an initial application to NICE was rejected as well back in 2020. This is a huge […]

July 7, 2023

Published by Meranda Parascandola at July 7, 2023

Navigating the Complexities of Supply Chain Management in the Biotech and Pharmaceutical Industry

As a supply chain expert in the biotech and pharmaceutical industry, I understand the unique challenges faced by companies operating in this highly regulated and complex sector. Supply chain management is critical for ensuring products are manufactured, transported, and distributed safely and efficiently while maintaining compliance with regulatory guidelines. In […]

July 26, 2023

Published by Meranda Parascandola at July 26, 2023

Why You Should Consider a Biologics Consulting Service

Biologics are complex molecular entities that require extensive planning and development strategies to control development costs, ensure compliance with regulations, and speed up a product to commercialization. Hiring a biologics consultant ensures you receive expert advice and support throughout the entire CMC development process. In this article, we will outline why you should consider a biologics consulting service and what benefits this will have for your company.

August 18, 2023

Published by Meranda Parascandola at August 18, 2023

COVID-19 and Pharmacovigilance Findings from EMA and MHRA

The drug safety environment is heavily regulated and continuously evolving, with numerous compliance challenges. Since the start of the COVID-19 pandemic, many pharmacovigilance monitoring activities have taken place remotely. Insights gleaned from these reports can help companies remain compliant when conducting pharmacovigilance during COVID-19 and beyond.

August 26, 2023

Published by Meranda Parascandola at August 26, 2023

The Analytical Detective: Benefit-Risk Balance and the Analytical Testing Process

In any pharmaceutical development program, there are risk-benefit analyses being done to assist with decision-making processes. Expedited development presents a different balance to a company’s risk-benefit in order to bring a particular molecule forward as quickly as possible because of the potential benefits.

September 7, 2023

Published by Meranda Parascandola at September 7, 2023

PHASE 2 TO EARLY PHASE 3 REGULATORY OPPORTUNITIES: RETURN ON INVESTMENT

The drug safety environment is heavily regulated and continuously evolving, with numerous compliance challenges. Since the start of the COVID-19 pandemic, many pharmacovigilance monitoring activities have taken place remotely. Insights gleaned from these reports can help companies remain compliant when conducting pharmacovigilance during COVID-19 and beyond.

September 18, 2023

Published by Meranda Parascandola at September 18, 2023

What is a Quality Management System?

A robust Quality Management System (QMS) is an important aspect of a Pharmaceutical company as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.

September 25, 2023

Published by Meranda Parascandola at September 25, 2023

DECENTRALIZED CLINICAL TRIALS FOR DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES

Usually, activities in clinical trials are conducted in clinical trial sites that are experienced or well-versed in clinical trials. In fully decentralized clinical trials (DCTs), all activities occur at locations other than traditional trial sites, such as at the homes of trial participants or in local healthcare facilities that are convenient for trial participants

October 25, 2023

Published by Meranda Parascandola at October 25, 2023

Project Management: A Complex Necessity

Many pharma and biotech startups may question the idea of whether a Project Manager is really useful; is it simply another layer to add to the complex array of personnel and job responsibilities? There are a number of tools available; most commonly recognized among these is the classic Gantt chart – so why add another person to the mix just to manage that?

December 6, 2023

Published by Meranda Parascandola at December 6, 2023

What Role Does ERP Play in Supply Chain Management?

Supply chain management is fundamental to business success. The past few years have demonstrated the importance of robust supply chain processes, from the security of raw materials to the optimization of business processes to maximize operational efficiencies.

December 12, 2023

Published by Meranda Parascandola at December 12, 2023

Quality Resolutions

There are no holidays or time off when it comes to complying with regulations. Companies always need to be ready to meet the latest standards. With that in mind, new FDA programs are sure to keep pharmaceutical companies of all sizes busy in the year ahead. Here’s how to get through.