Medical Writing
Emtex medical writers have the required know-how and skills to provide you with professional medical writing services across a wide variety of therapeutic fields.
Regulatory medical writing Medical communicationsBy working with EMTEX you get tremendous advantages:
We can help you to meet your deadlines, maintain high quality and/or reduce the cost.
Outsourcing to companies, like EMTEX, that have staff with medical background and technical knowledge of the regulations increases the speed of work. The demand for high quality documents is also increasing as the difference between poor-quality and high-quality medical writing can mean the difference between a speedy drug submission and approval, and a rejection.
Although the pace of drug development is constantly increasing, most individual companies do not have many regulatory submissions and reports. For the companies that have an occasional regulatory submission, maintaining a medical writing team is challenging and can be a drain on resources.
High mobilization rate in the pharmaceutical and biotech industry poses a big challenge to the development and maintenance of a medical writing department in pharmaceutical and biotech companies. Further, the bulk of medical writing tends to be piled towards the beginning or the end of the clinical studies, whereas, in between, the medical writing department tends to have idle staff waiting for work.
Company-employed medical writers have a propensity to share insular views that companies have regarding their own products. On the other hand, by outsourcing, these companies get an added advantage of the range of experience and unbiased attitude that external writers can provide.
Our broad experience in the development of documents for different products and therapeutic fields allows us to deliver clear and well-structured documents. We guarantee high quality services in a timely fashion and according to your company standards (e.g. standard operating procedures, document templates and style guidelines).
Great things in business are never done by one person. They're done by a team of people.
Regulatory medical writing
Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics. Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents that summarize and discuss the data a company gathers in the course of developing a medical product. Below you can find an overview of the most common document types EMTEX writes:
- Summary of Product Characteristics
- Summary of Clinical Safety
- Summary of Clinical Efficacy
- Risk Management Plan
- Periodic Safety Update Report
- Pediatric Investigation(al) Plan
- Narratives
- Investigator Brochure
- Investigational Medicinal Product Dossier
- Informed Consent Form
- Drug Safety Update Report
- Clinical Trial Protocol
- Clinical Study Report
- Clinical Overview
- Clinical Development Plan
- Case Report Form
- Briefing document
- Benefit Risk Assessment Report
Medical communications
Medical communications means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, consumer education and programs and enduring materials for continuing education or continuing medical education. A few of the document types in this area are:
Please note that we can provide more Medical Writing Services and solutions tailored to your needs. At the start of every project, we arrange a kick-off meeting to gain insight into the specific requirements and needs of your company or product.