case studies
Pharmaceutical consulting services
1.0 Case study
We were asked to provide support to a research-based drug discovery company.
• Design of a pharmaceutical compound selection process
• Salt and morphic form selection
• Development of pre-clinical formulations for toxicology testing
• Preformulation studies as part of compound selection
• Design and development of materials for 'First in Man' studies
• Selection and supervision of the manufacturer of clinical materials
• Development of the manufacturing elements of the Investigational
Medicinal Product regulatory dossier
• Supervision of the clinical trial packaging operation on the behalf
of the sponsor
Our contribution enabled company to move forwards cost-effectively and quickly, saving substantial amounts of time and money.
Our unique expertise opened up new possibilities and ideas to our client, increasing their chance of a successful product development.
2.0 Case study
Successful interim management requires sensitivity to organisational history as well as high levels of technical competence. We provided short and long-term support for a wide range of small and large companies:
• Management of a major development department of 60 people engaged in product development and manufacturing
• Ongoing technical development to teams on a one day per week basis over extended period
• Short-term full-time support to due diligence, and regulatory dossier compilation teams
Client was delighted to get manager with skills able to quickly tackle
major organisational issues including identifying a permanent successor from within the organisation. At the same time were able to improve standards of development and manufacturing in a way existing staff were able to accept.
Quality assurance and compliance consulting
1.0 Case study
A concerned client had problems with quality control tests and asked for our help.
The product was a key part of the manufacturing process for a number of important drugs. Product batches were failing key release tests. This lead to problems with supply of product to customers, as failed batches could not be used.
We suspected tests were not performing consistently and producing misleading results rather than any manufacturing problem.
We confirmed the failed batches were perfectly acceptable and produced reliable tests.
• We analysed problem in depth
• Prepared validation protocols for improved tests
• Provided support in execution of validation protocols
• Prepared validation report
2.0 Case study
A multinational client required development and implementation of a
Quality Management System in order to operate to GMP.
We designed and implemented a system to suit structure, operations and culture of company. An interim QA Manager was appointed to
oversee project.
