DyFrNd

PROJECT BASED
CONSULTING

Get expert support for projects at the operational, technical, regulatory/quality and scientific level, with a focus on analytical chemistry and its applications in lab testing.
DyFrNd specializes in serving the pharmaceutical and medical device industries, addressing both emerging needs and established regulations. Key areas include Extractables and Leachables testing, analytical method development and validation, and material qualification in line with USP and EP requirements.

SCIENTIFIC
SUPPORT

Discover a pragmatic, operational, and scientifically sound approach to solving challenges. DyFrNd carefully analyzes each case, diving deep into the science when needed, and provides practical solutions while maintaining overall compliance.
Get expert advice on establishing a qualified analytical laboratory, ensuring its equipment, applications, and methodologies meet accredited lab standards.

REGULATORY
UPDATES

Stay ahead in compliance with insights on regulatory updates, guidelines, and upcoming changes. DyFrNd translates these into practical, applicable needs for your business through thorough scientific and operational reviews.
Gain a deeper understanding of what it takes to maintain a fully qualified analytical laboratory—beyond method accreditation. This includes equipment management, data integrity, and proper staff training to meet quality standards such as ISO 17025.

LAB TECH
TRAINING

Gain a deeper understanding of the most commonly used analytical test methods—beyond just written procedures. Develop a fundamental knowledge of the scientific principles behind these techniques and their associated methods. This foundational expertise is essential for lab analysts, enabling them to better interpret test results, optimize equipment use, and apply best practices for more efficient overall performance.

WORKSHOPS &
EDUCATION

Stay ahead with updates on regulations, testing approaches, and guideline requirements. Gain insights into the qualification of raw materials and equipment, as well as current market needs and emerging trends through workshops, webinars, and educational programs. Acquire practical knowledge applicable to various testing labs and industries, including pharmaceutical and medical device sectors, covering both existing and innovative analytical methods.

Main domains of expertise

Analytical chemistry projects for the pharmaceutical and the Medical Device industry, a.o. the design, execution and evaluation of Extractables and Leachables (E&L) and chemical characterization studies being the core expertise, next to monograph testing and other regulatory requirements for the use of polymeric (raw) materials and container closure systems (pharmaceutical packaging).

In-depth scientific knowledge and leverage of expertise for analytical laboratories and the industries evaluating the analytical results.

Education of the Pharma and Medical Device industry and individuals in the continuously changing regulatory environment to stay compliant. Examples include both USP and EP monographs for the pharmaceutical packaging and drug products (e.g. USP 1661/1662/1663/1664, EMA Guideline on plastic immediate packaging materials) and material qualification requirements (e.g. the EP 3.1/3.2./3.3 monographs, USP 661.1/661.2/665)

Strengthen fundamental scientific knowledge within analytical laboratories and for its lab analysts by providing basic or in-depth training in a variety of techniques, e.g. from spectroscopic to mass spectrometric detection based technologies (i.e. from ICP/OES and fluorescence to single or triple quad MS), from monograph type of lab testing to method development and validation projects (ICH Q2(R2), USP 1225), from best practices to predefined System Suitability tests (USP 1058).

Basic and in-depth understanding of the Qualified State of the test methods and the analytical equipment used, e.g. for ISO17025 or GmP accredited labs, combining the regulatory needs with a pragmatic approach and operational excellence to provide the best service possible at the right science and quality standard.

Analytical Labs

Pharma
Industry

Knowledge & Education

Medical
Devices

DyFrNd is not restricted to specific assignments, tasks, domains, or projects. Our broad and diverse expertise enables to efficiently handle a wide range of projects and objectives. Whether small or large, every project is managed swiftly and flexibly, ensuring that both the approach and outcome are tailored to the intended purpose.

Our expertise combines regulatory knowledge and guidelines with hands-on skills in designing and executing physico-chemical studies. It includes a deep understanding of the science behind methods and results, a no-nonsense approach to achieve defined objectives, and strong presentation and teaching abilities—all aimed at empowering others to reach their full potential.

Focus on achieving the expected results through a transparent approach, setting clear and realistic objectives upfront through mutual agreement. Ensure thorough, high-quality, and scientifically sound work, delivered on time. Leverage the power of customized solutions that are trustworthy, reliable, flexible, and backed by scientific principles.