Good stories

Validation and Implementation of a New Analytical Test Method

A leading Nordic pharmaceutical company needed to implement a new test method to ensure the quality of a new therapy for clinical studies in humans. Emendo R&D was brought on board the project to actively participate in the development, validation, and implementation of the method.


The Challenge

To ensure the quality and safe use of a novel drug substance for clinical trial material, a Nordic pharmaceutical company sought assistance in implementing a new analytical method.

The main challenge was to facilitate the smooth transition of the analytical method from one department to another within the company. The two departments operated under different conditions, with one department focused on method development without the constraints of GMP, while the other department operated under both the strict regulatory framework of GMP and had no prior experience with the method.

The transition required a thorough understanding of the needs and requirements of the receiving department to ensure compliance while maintaining the accuracy and reliability of the analytical method throughout the process.

The Solution

Validating and implementing a new analytical method

Emendo R&D was entrusted with the overall management of the project and led the validation and implementation phases of the new analytical method within the GMP-regulated development unit.

This involved mapping and coordination over 20 activities across 5 functional areas, defining the analytical strategy, and providing training to technicians and scientists in the method, all while ensuring compliance with current guidelines (ICH Q2) and the company’s quality management system.

As part of the solution, Emendo R&D developed Standard Operating Procedures (SOPs) for the method and the instrument used in the analysis. In addition, Emendo R&D created guidelines for data analysis, protocols and reports that could be presented before the regulatory authorities during audits.

The Results

By partnering with Emendo R&D, the company achieved a smooth transition between departments. The uncertainty associated with the introduction of a new analytical method was removed and the foundation for robust analysis was laid. The result was an empowered team with the confidence and ability to perform the appropriate analyses and meet future challenges.

“By partnering with Emendo R&D we’ve been able to implement a new analytical method in our department which has helped us ensure the quality of a new drug substance. Emendo R&D has provided valuable scientific knowledge, driven the project with great oversight and enthusiasm, and has ensured a smooth transition of the analytical method to our department. We’ve been very pleased with the process.”

Head of the department at the client

“We recognize that projects are not driven by software, processes or tools, but by people. By putting people at the center of everything we do and giving credit to those who are committed to the project, we have not been only able to create great synergy between Emendo R&D and the client, but also overcome the challenges we have encountered along the way.”

Andrés Bueno Venegas
Scientific Lead Consultant, Emendo R&D

Ensuring a smooth transition from start to finish

Working closely with the client, Emendo R&D was responsible for:

  • Driving the validation of a new analytical method/procedure established within a GMP-regulated development department.
  • Ensuring a smooth transition of the analytical method from the sending unit (the department that developed the method) to the receiving unit.
  • Identification of all activities to be performed in order to successfully validate the method.
  • Coordination of the various activities related to method validation across more than 5 departments (Regulatory, Quality Assurance, Research, Drug Product Development, Drug Substance Development, etc.)
  • Developing the analytical strategy and outlining the analytical target profile of the method in accordance with ICH Q2 guidelines.
  • Introductory training for technicians and scientists.
  • Development of standard operating procedures for the method and instrument.

Contact Andrés

To learn more about this project, please reach out to Andrés Bueno Venegas.

Andrés Bueno Venegas

Andrés Bueno Venegas

Scientific Lead Consultant

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