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R&D & Validation Activities for the Pharmaceutical Industry

At Mérieux NutriSciences | Pharma & Healthcare, we specialize in delivering comprehensive Research and Development (R&D) and validation services for the pharmaceutical industry. Our team of experts is dedicated to ensuring the highest standards of quality, safety, and efficacy at every stage of your product’s lifecycle.

Pharma Service Catalogue

Complete List of Technologies


R&D & Validation Activities: Our Lab

Our laboratory is dedicated to providing cutting-edge research and development services, as well as robust method validation, ensuring the highest standards of quality and compliance in the pharmaceutical industry.

Expertise & Experience in R&D & Validation Services

  • Our team comprises highly skilled professionals with extensive experience.
  • Customized Solutions: We understand that each project is unique. Our flexible and tailored approach ensures that we meet your specific needs and objectives.
  • The R&D Corporate Department, based in Italy, serves as the referral lab for:
    – Contaminants Research at MxNS global level
    – Analytical Innovations
    – Strategic projects with Academia and International Industry Partners
  • We have extensive experience in forced degradation studies and development and validation of stability indicating methods.

Cutting-Edge Technology

  • We utilize the latest technologies and methodologies to deliver accurate and reliable results.

Commitments

  • Quality is at the core of everything we do. We are dedicated to maintaining the highest standards in all our services.
  • Regulatory Compliance: We adhere to global regulatory standards, ensuring that your products meet all necessary guidelines and requirements.

Our Experts

R&D & Validation Activities

  • Fine chemicals
  • Active ingredients
  • Excipients
  • Additives
  • Finished products

Quality is always an essential factor in relation to any product, and is even more critical in the case of life-saving products such as pharmaceuticals.

The concept of validation refers to a set of activities designed to demonstrate and document that a specific product can be reliably manufactured by the defined processes (so it is closely related to the substance quality).


Analytical Method Development

We offer robust analytical method development and validation services to support your drug development process. Our team employs state-of-the-art technology and follows stringent regulatory guidelines to ensure reliable and reproducible results. Key services include:

  • Development of new analytical methods
  • Optimization and validation of existing methods
  • Method transfer and verification
  • Forced degradation studies
  • Identification of unknown impurities
  • Identification of foreign particles
Analytical Method Development

Method Validation

As part of the validation process, our experts check the following:

  • Specificity (including stability-indicating verification)
  • Accuracy
  • Precision (repeatability, intermediate precision, reproducibility)
  • Limit of detection
  • Limit of quantification
  • Linearity
  • Range
  • Robustness
  • Solution stability