---
title: Pharma consulting in manufacturing transfer and scale-up for Phase III trials
description: Pharma consulting in manufacturing transfer and scale-up for Phase III trials
---

[Case Studies Archive - Alacrita ](https://www.alacrita.com/case-studies)

# [Pharma consulting in manufacturing transfer and scale-up for Phase III trials](https://www.alacrita.com/case-studies/pharma-consulting-manufacturing-transfer-scale-phase-iii-trials)

 Written by [John Simpson](https://www.alacrita.com/case-studies/author/john-simpson) | Feb 14, 2017 12:40:30 PM

## Challenge

A small biotech company had undertaken several projects in clinical development and needed focused CMC consultancy support in progressing to the next phases of these ventures.

## Solution

Our CMC consultant worked with the client, providing the necessary expertise at key points of the development of two projects. Our support included:

- assessing the CMC package available for an oral compound (novel small molecule) in late stage Phase II clinical trials and writing a report to establish key requirements for a US and European product license submission
- helping assess formulation characteristics and substance characterization — for an oral compound that showed batch to batch variability in dissolution profiles
- developing a new particle size method for both milled and unmilled drug substance
- managing the transfer of product manufacture between sites in the UK and France, and the scaling up and manufacture of Phase III supplies
- providing significant input into a regulatory document seeking scientific advice from the FDA prior to Phase III studies

[View full post](https://www.alacrita.com/case-studies/pharma-consulting-manufacturing-transfer-scale-phase-iii-trials)

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