The Chemistry, Manufacturing, and Controls (CMC) division is pivotal in pharmaceutical production, ensuring product quality, safety, and efficacy. From developing robust analytical methods to overseeing manufacturing processes and quality control, the CMC department is essential in bringing effective and compliant drugs to market.

Technical due diligence (or gap analysis) is the process of thoroughly examining all aspects of a product, including identifying risks and confirming its value by meticulously reviewing documentation, information, data, records, and other relevant materials.

Venn has a 15-year track record in offering PMx programming and translational modelling and simulation (M&S) services to the pharmaceutical industry. We are the preferred partner in clinical pharmacology to major pharma for both FSP and project-based engagements. 

We integrate quality at every stage of product and service development. Our experience in navigating the complex regulatory landscape ensures that your processes align with current standards, and you are prepared for the foreseeable future demands.

Venn Life Sciences, part of the hVIVO plc, is an Integrated Drug/ATMP Development Partner offering a unique combination of pre-clinical/CMC development expertise, clinical trial design and management. That enables to create, plan, and execute the development programs effectively and seamlessly for the clients.

Venn provides data-centric End-to-End Trial Support, providing data driven trial design and methodology. The Service Sheet describes where Venn designed a single seamless phase II/III adaptive pivotal study, supporting the marketing authorisation application for a product in a high unmet medical need in a pediatric indication.

For over 25 years, the clinical pharmacokinetic (PK) and pharmacodynamic (PD) team of Venn Life Sciences have supported (model-independent) noncompartmental (NCA) PK and PD analyses for top ten pharmaceutical companies.

The CMC regulatory team has 20+ years’ experience supporting several pharma (small and large molecules) and medical device companies to ensure the continual manufacture and supply of high quality products to patients in licenced global markets.