About us

Cerebro CMC supports companies involved in the development of pharmaceuticals and biopharmaceuticals. Our consultancy service is focussed on the CMC (chemistry, manufacturing and control) aspects that are a critical component of the overall drug development programme. We are experts in the development of production processes and analytical methods, offering technical and quality consulting, from process development through to GMP manufacturing. Whether your challenge is an entry to Phase 1 studies or the complexities of Phase 3 registration, we integrate into your in-house team to select and manage your outsourced activities.

EXPERTISE

Cerebro CMC’s consultants are experts in the technical, operational and quality elements required for the development of small molecule and biological drugs.

We deploy experts with either the breadth of skills to manage whole CMC programmes or with the depth of skills to dive deep into specific disciplines: analytical validation, process development, technology transfer, manufacturing, stability, formulation, quality management systems.

All of our consultants have many years of experience directing contract development and manufacturing organisations, gaining a strong understanding of the regulatory requirements for a successful CMC package.

Packages

In addition to our general consulting services, we have developed a number of service packages that meet certain needs of many of our clients. A defined approach and existing templates ensure we can efficiently and quickly complete the scope of work for each service package, achieving clear deliverables and a successful outcome.
 
For more details, visit our packages for:

What our clients say

“Depth of technical knowledge aligned to a strong personal initiative to get things done, whilst at the same time ensuring quality standards and budget constraints are adhered to”

Dave Walker Senior Director Clinical Development

“Technical knowledge and pragmatic style have contributed to the successful completion of an important project milestone”

John Graham Director CMC and Pharmaceutical Development

“Provided thoughtful strategy and strong tactical implementation to deliver our [CMC] objectives”

Rod Richards, CEO

“A valuable partner in contract negotiation, communication with CMO, interpretation of data and problem solving”

Paul Little VP Preclinical & CMC

Showcase

 

Tech Transfer

 

A large pharma company was looking to transfer a wide-ranging portfolio of marketed consumer health products, some medicinal and some food supplements, from in-house GMP manufacture to third-party contract manufacturers. Support included: technical leader for tech transfer team, overseeing product risk analysis and transfer planning; technical resource to perform in-depth CMC health check of existing operations; joint quality leader, managing analytical validations and transfers, and executing a large number of stability studies; on-site support at sending site and receiving sites. The support resulted in successful establishment of GMP operations at the CMOs and valuable data for decision-making on the commercial viability of products within the portfolio.

Early Phase Manufacture

 

A single asset development company was looking to establish a virtual development team to achieve proof of concept for a novel synthetic peptide. Support included: managing the secondary manufacturing of clinical IMP at CMO; arranging GMP audits of CMOs; coordinating clinical supplies for Phase 2 studies; selecting formulation development partner and overseeing development of an optimised formulation; technical and quality management of long-term stability studies; writing of CMC sections of Investigators’ Brochure and IMPD. As a result, several clinical studies were completed.

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