The Services

The way of a product from the beginning of the first experiments in the laboratory to an approved medicine is a long way and has to be continuously monitored by a high effort of documentation.

Jelinek Scientific Documentation GmbH offers project specific support for companies in the field of analytical laboratory, biotechnology and pharmaceutical industry for:

Research and Development

• Writing of scientific reports
• Support in validiation and qualification issues
• Review of development reports
• Consulting and training in development and structure of documentation systems
• Customer-specific requests

Quality Assurance

• Support in implementation of a quality assurance system
• Preparation of new standard operating procedures (SOPs)
• Review of existing SOPs
• Training
• Customer-specific requests

Regulatory Affairs

• Collaboration in submission documentation (e.g. CTD part, QoS)
• Review of documents and support in communication with the authorities
• Preparation of summaries, briefing documentation and presentations for meetings with authorities
• Customer-specific requests

Research and development, quality assurance and regulatory affairs, no one of these departments is isolated in the complete process to the approval of a new product. Our aim is to develop a system of documentation specifically tailored to your company that interlinks ideally the documents of the different departments.

Jelinek Scientific Documentation GmbH is focused on consulting and support of your documentation, and you benefit by the long-time of professional experience in interdisciplinary work with documents:

flexible - fast - accurate

Additional tasks regarding documentation, for example translations (German - English), trainings or the preparation of presentations are equally elaborated as your specific questions.

We'll be pleased to receive your inquiry at any time.