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Kymos Group, S.L offer service "Method Development, Validation and Transfer"

Basic Information

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Trade Type

Offer Service

Service Name

Method Development, Validation and Transfer

Service Provider(s)

Specifications

  • Service Type: Chemistry, manufacturing and control (CMC) analytical method development, validation and transfer for excipients, APIs, intermediates and finished products
  • Certification Standard: Follows ICH Q2(R1) and FDA guidance, applying Quality by Design (QbD) strategies; method transfer performed per EU GMP Chapter 6
  • Equipment Compatibility: Supports comparative testing, co-validation across two sites, or revalidation to enable successful method transfer

Other Information

Additional Description:

Kymos Pharma Services offers chemistry, manufacturing, and control analytical services in medicinal chemistry, including method development, validation, and transfer. Its team has deep experience developing and validating proprietary and non-proprietary methods for excipients, APIs, intermediates, and finished products, following ICH Q2(R1) and FDA guidance and applying QbD strategies to strengthen results. Methods are prepared for transfer to contract-givers in line with EU GMP Chapter 6, via comparative testing, co-validation across two sites, or revalidation.
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