The Essential Guide to Safety, Quality, and Trust Across Regulated Industries

Achieving Quality and Conformity

The term "immunogenicity" describes a substance's capacity to trigger an immune response in humans;

Medical device efficacy and safety have always been of utmost significance in Europe.

Pediatric toxicology focuses on the adverse effects, remedies, and prevention of hazardous chemicals in kids.

Uncovering the Hidden Truth

Exploring into the herbal industry of Europe.

Our previous blog we spoke of Advanced E-Pil. So, let’s explore on something that many of us didn’t know, the science behind cannabis in the pharma industry.

In our previous blog we spoke on what is PK/PD? In this blog, we will be looking into something related with technology.

On our previous blog we spoke on impurities. So, let’s explore something new. Do you know what’s the connection between a drug and human body? Well on todays blog will find out some of the common doubts on PK & PD.

In this blog, impurities are explained in depth on the pharmaceutical approach.

In our previous blog, we gave you a clear idea of what is a cell, how it functions, and the purpose behind it. In this blog we are will be sharing something that is interesting about cell banking and testing. 

With the gradual increase of these Systems, many manufacturing companies took this as an advantage to dwell into the field of pharma manufacturing. As a result, a need raised to come up with a foolproof and risk-free system.

When ICH initiated the guidelines on Clinical studies and Clinical Trials, a set of principles and practices were laid out to ensure that the design and structure of conducting clinical trials.

Sponsors are under additional pressure to increase efficiency while preserving quality as a result of clinical studies becoming more complex as more data is collected.

Characterization and analysis of advanced therapy medical products (ATMPs) are crucial for delivering the crucial chemistry, manufacturing, and control (CMC) data required for submission in investigational new drug applications.

For products made from cells, cell bank characterization is a crucial quality-control procedure. A well-established cell bank is essential to guarantee there is an appropriate supply of similar cells for use for the course of the product's complete life span once a cell line is selected as its biological source. 

Children should receive medications that are customized for them. Over the past few decades, there has been a growing awareness of the necessity of involving children in the drug development process.

Key Account Management (KAM) in the Medical Sector, Prescription authority has recently been divided across organizations, committees, or networks of medical, social, administrative, payer, and patient representatives.

The evaluation of spontaneous reports are obtained when it is carried out within the strict and well-defined good pharmacovigilance procedure framework,

Setting milestones, risk management, allocating employees and money, and dealing with clients and contracts are all examples of clinical project management.

Vaccines are one of the most significant advances in public health, and finding new vaccines continues to be one of the most difficult tasks we face.

Chemical contaminants, bacteria and fungi, and viruses all pose threats to biological and biotechnological goods. Transmission of viral infections is a genuine possibility with these items.

Stability testing is an important aspect of product development and is carried out throughout the life cycle of a product. Stability is part of a biotherapeutic's quality desired product profile, and the results help analysts understand how temperature, relative humidity (RH), light, storage, pH, and other factors affect critical quality attributes (CQAs) of both medicinal ingredients and products.

Choosing a pediatrician is one of the most important and challenging decisions you'll make about your child's health. Whether your child has already entered the world or is due any time soon. A pediatrician is a doctor who focuses on children's physical, behavioral, and mental health.

Quality Risk Management (QRM) is the process of identifying, evaluating, and mitigating recognized risks connected with medicines and healthcare goods. An excellent Quality Risk Management programme can be created to reduce risk to a manageable level and deliver high-quality products to protect citizens' health.

A contract is one of the most important components of any industry or corporation, and conducting business or engaging in any form of collaboration without one may be a nightmare for all parties involved.

The audit in the sense a systematic and independent examination of activities to identify whether the evaluated activities were performed according to decided requirements.