Beyond standards

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

A Medical Company wanted a new, faster, more robust disinfection process in their IIb class medical devices.

The Project Management Community was created to bring together a group of consultants working on project management assignments, create a mutual support network and share problems and solutions.

Medical Device Manufacturing Process optimized for Qualitative and Faster Production

Pharmaceutical and biotechnology regulatory affairs is a complex and ever-changing field, where non-compliance and non-compliance with requirements can result in severe penalties, fines and reputational damage. This poses many challenges to the pharmaceutical industry, which can be described in the different stages of the healthcare product life cycle: Strategic regulatory planning at the development stage […]

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

A Medical Company wanted a new, faster, more robust disinfection process in their IIb class medical devices.

Computerized Validation System

The Project Management Community was created to bring together a group of consultants working on project management assignments, create a mutual support network and share problems and solutions.

We launched the RA MD community because the Medical Device (MD) industry is evolving in several aspects now, especially on Regulatory Affairs (RA).

Discover the thriving Analytical Quality Control community designed to connect, educate, and empower consultants in physical-medical QC.

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

The Significance of Automation in UHPLC Analytics for Precise and Efficient Results

The healthcare industry is a dynamic field that offers a myriad of opportunities for career growth and professional development.

A new eQMS improves management processes. The implementation of Enhanced CSV aims to ensure the accuracy, integrity, and compliance of data.

In the world of pharmaceutical analysis, High-Performance Liquid Chromatography (HPLC) has been a workhorse for many decades. However, with advancing technology, Ultra-Performance Liquid Chromatography (UPLC) has emerged as a promising alternative.

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

The Significance of Automation in UHPLC Analytics for Precise and Efficient Results

In the world of pharmaceutical analysis, High-Performance Liquid Chromatography (HPLC) has been a workhorse for many decades. However, with advancing technology, Ultra-Performance Liquid Chromatography (UPLC) has emerged as a promising alternative.

The Project Management Community was created to bring together a group of consultants working on project management assignments, create a mutual support network and share problems and solutions.

Ensuring Compliance with Monograph Updates: Testing Analytical Methods for Two Raw Materials

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

A Medical Company wanted a new, faster, more robust disinfection process in their IIb class medical devices.

The Project Management Community was created to bring together a group of consultants working on project management assignments, create a mutual support network and share problems and solutions.

Medical Device Manufacturing Process optimized for Qualitative and Faster Production

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

The healthcare industry is a dynamic field that offers a myriad of opportunities for career growth and professional development.

A new eQMS improves management processes. The implementation of Enhanced CSV aims to ensure the accuracy, integrity, and compliance of data.

Computerized Validation System

The Project Management Community was created to bring together a group of consultants working on project management assignments, create a mutual support network and share problems and solutions.

Ensuring Business Continuity in Pharma. Navigating challenges with XPLM and QIQO to ensure the continued supply of a vital coagulation factor.

A Medical Company wanted a new, faster, more robust disinfection process in their IIb class medical devices.

The Project Management Community was created to bring together a group of consultants working on project management assignments, create a mutual support network and share problems and solutions.

We launched the RA MD community because the Medical Device (MD) industry is evolving in several aspects now, especially on Regulatory Affairs (RA).

Medical Device Manufacturing Process optimized for Qualitative and Faster Production

As an integral part of the healthcare world, the medical device industry must comply with a dedicated regulatory framework to protect the patient and ensure health benefits. The different tasks of the AR department imply a central position in the internal and external interactions of the company. The manufacturing of a DM is organized according to a "Supply Chain". It includes the different departments of the company, whether technical, support or commercial, but also numerous suppliers and subcontractors. Since regulatory requirements apply to the entire manufacturing process, the RAs interact with all the players involved, particularly through regulatory audits.