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Technical Writing.

Ensuring experienced input to your dossier.

Effective technical writing requires expertise in many areas including scientists, pharmacists, and medical doctors. As all parts of your dossier are equal in importance this essential knowledge and medical practice experience comes together in our expert advice and creation of the clinical and nonclinical modules of your dossier (M2.4, M2.5, M2.6, M2.7, M4, and M5), and Environmental risk assessments (M1.6.1 and 1.6.2).

Our team can prepare these modules for full or abridged dossiers depending on the type of application and product nature, including biologic products that are non-GMO or GMO based.

We can also provide this expert support with the creation of product information based on product indications and provide extensive consultation regarding the preparation of promotional materials.

Dr. Oleksander Shatilov talks about our technical writing services…

Technical Writing Oleksander Shatilov
Dr. Oleksander Shatilov
Regulatory Affairs Manager