Transactional Content Management

PRODUCTS

  • 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.

  • Protect your pharmaceutical products from any potential damage during their line transit. Integrate nests or trays into your line transport processes with our flexible, customizable options.

  • Single-use, automated filtration system designed to deliver robust process control during the clarification/harvest step.

  • There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

  • Electronic informed consent for patient-centric decentralized clinical trials.

WHITE PAPERS AND CASE STUDIES

NEWS