Expertise.
Medical Writing.
Creation of precise, compliant and well-structured documentation for the pharmaceutical, biotech, medical technology and IVD industries.
Compliant?
Does your documentation meet the regulatory requirements for submissions to authorities?
Secure?
Are your clinical studies and reports clearly and comprehensibly documented?
Efficient?
Do you want more efficient processes for creating approval documents and reports?
Optimize your medical writing processes now!
Medical writing - precision and expertise for your documentation.
Our medical writing services support you in creating precise and compliant documentation that meets the requirements of the pharmaceutical, biotech and medical technology industries.
Whether clinical study reports, approval documents or scientific publications - we offer you tailor-made solutions that meet the complex regulatory requirements while using clear and understandable language. Our medical writing experts have extensive experience in preparing reports and documents for submission to authorities such as the FDA and EMA.
We support you in the creation of:
- Regulatory documents such as Common Technical Documents (CTD), clinical trial data and approval documents
- Clinical reports including CSRs (Clinical Study Reports) and protocols for studies
- Scientific publications and abstracts for conferences and journals
Medical Writing Services at a glance.
Our comprehensive medical writing services support you in all aspects of documentation, from submission to publication.
Regulatory documentation.
- Creation of CTD modules (Common Technical Document)
- Support with approval documents for authorities
- Technical documentation according to MDR/IVDR
Clinical documentation.
- Writing Clinical Study Reports (CSR)
- Preparation of study protocols and patient data
- Support with clinical development plans
Scientific publications.
- Writing scientific articles and abstracts
- Compilation of manuscripts for specialist journals
- Creation of presentations and posters for conferences
Case studies: Successful projects in the field of medical writing.
Our medical writing projects help companies to meet regulatory requirements and organize their documentation efficiently. Here are three examples of how our services have led to measurable success.
Efficient creation of approval documents for a pharmaceutical company
Clinical reporting for a biotechnology company
Scientific publication for a medical technology company
Challenge.
A pharmaceutical company needed support with the preparation of CTD documents in order to obtain approval for a new drug on time.Measures.
- Creation of the entire CTD module
- Close cooperation with the Regulatory Affairs team to fulfill all requirements
- Review and optimization of documents in accordance with EMA guidelines
Results.
- Timely submission of the CTD document
- Successful approval of the drug
- Improved efficiency and collaboration between departments
Success.
The company was able to submit the drug for approval on time and successfully enter the market.Secure your customized medical writing services now.
Our medical writing service portfolio.
Our portfolio covers all areas of medical writing, from regulatory documentation to clinical reports and scientific publications.
We create complete CTD modules and approval documents for authorities, including technical documentation according to MDR/IVDR. Our experts ensure that all regulatory requirements are met and that your submissions are made on time.
From Clinical Study Reports (CSR) to patient data, we provide you with clinical documentation that meets the stringent requirements of the FDA, EMA and other authorities. Our services support you in every phase of clinical development.
Our experts help you to publish your research results in renowned journals. We prepare scientific articles, abstracts, manuscripts, presentations and posters for conferences.
Optimize your medical documentation.
Related topics for high-quality scientific documentation.
These complementary services support you in creating precise and regulatory compliant documentation for your clinical and medical projects:
