PROVIDED SOLUTIONS
External CDMOs management and technical project management
We can support your scouting, selection and management of the external manufacturing sites, considering the current development stage and keeping in mind the intended final target.
Drug development outsourcing could be the only way to proceed and often this is left in the hands of the CDMOs, upon the simple verification of their GMP status. An advisor supports in keeping the work aligned with the sponsor’s goals and the regulatory targets at the usual market conditions.
CMC regulatory
The joint experience in problem solving on the ground and in presenting the results to the regulatory authorities by quality modules 2 and 3, is not common. This provides a notable benefit in translating the scientific and technical topics in understandable points by who expects correspondence with the guidelines’ requirements.
With more than 20 years of experience in submissions and applications and interacting with most of the health authorities in the world, both during applications and on the stage, we help partners in writing, reviewing and in gap analysis of dossiers, both investigational and for registrations.
We can also support in replying to the information requests moved by the reviewers.
Audits, GMP support and due diligence
We provide auditor/s for quality audits and mock inspections. They can be a single independent check within an internal training pathway or fit in a global PAI readiness preparation. Our experience covers inspections by different authorities (FDA, EMA, PMDA, ANVISA…) and can overlap the different requests from America, Europe and Asia.
With the technical experience we can also support in due diligence of new product/service suppliers and in the CMC reviewing of new projects.
The quality compliance is necessary for the site approval by the authorities, but it is not sufficient for sponsors who need more. An auditor who joins GMP knowledges with decades of external CDMOs managements can provide more than a simple QA auditor, being able to evaluate the quality and scientific gaps together with the interaction workflow which could create additional project risks.
Early and late-stage CMC support
CMC is fundamental in drug design ruling the route of administration with consequences in ADME and PK. However, this should be design keeping in mind the final market targets (patient benefit, regulatory expectations, product differentiation, supply chain scale and costs/risks control).
We have often worked shoulder by shoulder with non-clinical and clinician experts in the selection of candidate molecules, in drug characterization, and in minimizing the quality/safety risks during development or line extension programs. We brought several drugs to the launch accompanying them during the scale-up programs, processes’ improvement and validation. Coupling early-phase experience with late stage and launch experience is uncommon in biopharma industry where the specialization is high and where teams are often dedicated to specific targets or phases
Operations efficiency improvement
We can help in strengthening the efficiency of the processes, reducing the internal workflows and keeping the focus on the goals.
Often, the compliance to pharma guidelines is achieved by heavy overstructured systems and with loops among different responsibilities independently from the company sizes. Having experienced many different structures and with specific training for operations and team management, we can help in process and workflow simplification.