Our manufacturing and quality team cover medical devices, diagnostics, biologics and small molecules. Our team have held senior positions with key responsibilities and experiences including:
- head of a Medical Notified Body, responsible for planning, delivery and periodic review of effectiveness of certification service lines
- completing over 300 worldwide medical device and in vitro diagnostics audits
- preparing 510k submissions for in vitro diagnostics and active and non-active, sterile and non-sterile devices
- preparing technical files for CE marking for varying medical devices & in vitro diagnostics
- Qualified Person and Head of Quality for a leading biologics developer, having responsibility for ensuring quality throughout the organisation, from research through development to clinical trials, encompassing GLP, GMP and GCP
- applying broad experience in the manufacture and control of both terminally sterilized and aseptically prepared sterile pharmaceuticals, including ophthalmic products, lyophilized products, and creams and lotions, as well as most non-sterile dosage forms
Alacrita’s team also has expertise in preclinical and CMC, for example building multi-disciplinary CMC development groups, composing expert reports and quality overall summaries for EU filings. We have even been designated as “Experts” in CMC filings.
Case study: Providing pharma manufacturing consultancy during and after a buy-out
A large European biotech company had purchased a UK-based biotech company that was in the early stages of developing a potential breakthrough drug for treating arthritis. The parent company needed support in delivering the development programme during this transition.
Our CMC consultant worked with the company to deliver across a broad range of areas, including:
- drug substance manufacture, characterization and salt selection, developing of assays and stability testing
- formulation strategy and design to overcome poor bioavailability in both animals and humans
- regulatory submission for first-in-man studies, including a scientific advice meeting with the MHRA (Medicines and Healthcare Regulatory Agency)
- transferring manufacturing of drug substance and product between different sites and chief research officers
- a review of all manufacturing activities covering a period of five years
- a pharmaceutical and toxicological assessment for a regulatory scientific advice meeting, which had been prompted by the presence of a genotoxic impurity in an early batch of drug substance
- establishing and maintaining the development archive for the project and then transferring this to the new client’s head office
- due diligence activities
Further case studies regarding Manufacturing are available here.
Related Case Studies
Developing vaccine products
The UK HIV Vaccines Consortium needed expert advice. The consortium was supporting and coordinating the development of several new HIV vaccines in academia. They needed guidance about which...
Providing technical transfer and validation of a commercial manufacturing process for tablet formulations
A US biotech company had a small molecule anti-cancer drug on the market in the US and other products in development. The company needed CMC consulting expertise in...
Gap analysis of a US CMC data package for a European submission
A small regulatory company had been commissioned to review the development data package available from a US biotech company for a liquid inhalation product, with a view to...
CMC consultancy for a company developing a peptide
A small biotech company was developing a peptide and needed support in taking the compound to first-in-man studies and Phase II clinical trials. This was the first time...
GMP facility – feasibility study for biologics production
Drawing on expertise from its regulatory, gene therapy and manufacturing consultants, Alacrita conducted feasibility study and formulated a business case for a new GMP facility for production of investigational...
Due diligence – regulatory affairs
To help a clinical stage biopharmaceutical specialist company in its regulatory due diligence activities, Alacrita assembled an expert team comprising an ex-quality assessor who had previously worked in the...