Drug

Drug development is a long-term, highly complex, and strictly regulated process – from early development through preclinical studies and clinical trials to clinical use and beyond. Bringing innovative active ingredients and novel therapies to clinical use in a safe, effective, and high-quality manner requires both a forward-looking, holistic approach and the precise handling of individual regulatory steps, as well as suitable infrastructural conditions.

In the «Drug – Medicinal Product» sector, we offer three complementary services to support this purpose:

We support researchers and clinical professionals in holistically designing innovative medicines – from early development through to clinical application – in terms of both regulatory compliance and quality, ensuring they are safe, effective, and of the highest quality.

• Early, comprehensive consultation on drug development projects throug hout the entire translational pathway
• Strategic alignment of development programs in accordance with regulatory requirements
• Integration of GLP, GMP, and GCP requirements, as well as support with qua lity documentation
• Preparation for milestones related to clinical trials or potential approval, including benefit-risk assessments and regulatory dossiers
• Fostering the interface between science, clinical practice, and regulation through close project support

We handle clearly defined regulatory tasks in drug development, particularly the targeted planning, preparation, and submission of regulatory documents to the relevant regulatory authority.

• Handling specific, clearly defined regulatory work packages and subprojects
• Strategic planning of submissions for, e.g., scientific advice or clinical trials (e.g., Swissmedic and other authorities)
• Preparation, review, and timely submission of complete and formally correct documents
• Ensuring consistency between regulatory dossiers and parallel submissions to ethics committees in the case of a clinical trial

We advise and support projects in gaining access to the right facilities and expertise for quality-assured drug development.

• Coordinating access to suitable infrastructure, service facilities, and experts in quality assurance and regulatory affairs
• Assessing relevant quality and regulatory systems (GLP, GMP, GCP) and de termining the appropriate development path

Contact us now.