Range of skills

Sunnikan has a broad range of skills and know-how in a number of fields. Quality challenges are different in each, and require suitable solutions.

Managing Quality in Clinical Research

This is Sunnikan’s core business where it makes full use of its expert, comprehensive knowledge of the regulatory context, its skills in operational matters (Project Management, administrative formalities, monitoring, data management, statistical analyses), and its expertise in quality management.

Regardless of whether you are developing drugs, medical devices, or biotech or nutritional products, Sunnikan can offer you a full range of services adapted to meet the needs of industry and research.

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Managing Quality in Pharmacovigilance/Safety

Managing a pharmacovigilance system correctly requires in-depth knowledge of applicable regulations and operating processes, and a suitable high-performance Quality Management System.

Sunnikan has therefore developed solutions for its customers that are perfectly suited to the specific challenges of Pharmacovigilance: controlled delegation of responsibilities, risk management, regulatory traceability, validation of information systems.

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Managing Quality in Epidemiology

Epidemiological studies conducted for regulatory purposes are subject to the same validation requirements as clinical trials. And their regulatory framework is even more complex. Meeting these requirements means appropriate procedures, controlled processes, and validated information systems. Sunnikan’s experience in epidemiology means it can provide solutions that perfectly match these needs.

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Managing Quality in Regulatory Affairs

Players in the pharmaceutical industry (distributors, Marketing Authorization (MA) Holders, clinical trial sponsors) need quality assurance systems that guarantee conformity with applicable reglulations and control over processes. Sunnikan provides this industry with support through consultancy, training, audits, Standard Operating Procedures, etc.,

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Special support services for Biotech companies

Sunnikan offers a bespoke approach with advice and specific services to meet the specific needs of Biotech companies: regulatory advice for a development plan, quality management systems, clinical audits, etc.

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