Records Management

PRODUCTS

  • Maintain compliance with modular monitoring systems. Integrate particle counters and microbial samplers into a secure data framework to ensure integrity and streamline your batch release process.

  • We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.

  • We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

  • Go bigger, stay on target, and engineer the mammalian cell lines that get the job done.

  • Mikart’s development services include a range of pre-formulation capabilities for both oral solid and non-sterile oral liquid dose drug products.

WHITE PAPERS AND CASE STUDIES

NEWS