ClintraQ GmbH provides services to the pharmaceutical and life-science sectors, including scientific translations, support for clinical and preclinical trials, quality assurance, and regulatory documentation. Services include study monitoring, drafting of study documents and SOPs, auditing, and preparation of CTDs, expert reports and Tier 1/2 summaries.
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Industry:Management Consulting
✓ Offered6
Translations and texts
Write and edit medical-scientific texts, including technical and patient information, product monographs, promotional materials, scientific papers, SOPs, and study materials and documents.
Clinical research
Organise and monitor studies in accordance with GCP, prepare study materials, draft SOPs, ensure quality in studies, and provide GCP training for study personnel.
Quality assurance
Inspect preclinical study reports, carry out quality control of study protocols and patient information, perform audits during the practical conduct of clinical studies and in the GMP environment, and provide support for QMS systems.
Standard Operating Procedures (SOP)
Create, revise and update standard operating procedures for work steps under ISO, GMP, GLP and GCP for companies, CROs, physicians and laboratories.
Regulatory submission documents
Draft regulatory submission documents such as Tier 1 Summaries, Tier 2 Summaries, Expert Reports, Drug Master Files and Common Technical Documents.
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