Mindset

Our mission is to help customers achieving the best product quality with the minimum investment to enable decreasing the prices of new medicines and consequently increasing access to them, keeping in mind health authorities (HAs) requirements and regulatory guidelines. Our mindset is oriented to the application of Quality by Design (QbD), where possible, with focus on the following points:

• Developing a CMC strategy starting from the early phases of the drug development building the product quality into the manufacturing process;
• Minimizing QC testing focusing on the application of PAT and building sound scientific rationales based on development data.

For marketed products, developed without the application of QbD concept, we find alternatives to it analyzing the issues/changes and historical data to develop a scientific rationale to support the resolution of the problem and/or the implementation of the change with minimal investments.

The application of these principles will guarantee product compliance to HAs requirement, as well as product quality, safety and efficacy.

The ultimate goal is to build a long-term partnership to provide a high quality and efficient service with minimal client oversight, while leveraging productivity and cost advantages.

CMC Regulatory

We can support your business providing you with the following support: overall CMC filing strategy, GMP starting material definition, process control strategy, product lifecycle management (from IND/CTAs preparation to technical post-approval change management and variation filing).

Project Management

We can provide you with full project management including preparation of project plans, dashboards and periodic reporting for any kind of project from drug discovery to marketed product issue resolution.

CMO/S Connection

We will help you find the best partner for your needs. We will also provide you with the related technology transfer project management.

Dossier Module 3 Writing and/or Review

We can write the dossier for you or review it paying great attention to country specific requirements (in particular EU, US, Japan, Brazil, Russia, Mexico, Australia, New Zealand, China).

Process Validation

We will support you with drug substance process validation strategy definition. We will take care of the validation protocol preparation and of the final validation report.

Overall regulatory support

In cooperation with other regulatory consultants experts in pre-clinical and clinical development, we can support you in the overall filing strategy definition, in the product development strategy and we can provide you with an overall dossier gap analysis.

Technology Transfer

We can support you for any kind of tech transfer with full project management including project plan, dashboard, technology transfer protocol and report preparation.


 

DUE DILIGENCE

We will provide you with an overall CMC gap analysis of the product that you are considering for in-licensing, with great attention on the CMC regulatory aspects.