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About us
MediExcels is a medical writing consultancy, which offers reliable, detailed oriented and high-quality services for your pharmaceutical business needs.
Our experienced professionals are here to provide you with services that enhance your performance and elevate your position among the pharmaceutical industry.
In depth research
The fundamental of achieving excellence in pharmaceutical industry is through meticulous approach of understanding a subject, ensuring that all aspects are explored and analysed properly. This level of attention leads to more accurate insights and well-informed decisions.
Professionalism approach
Professionalism in medical writing is key to producing clear, accurate, and evidence-based content. It involves a strong commitment to scientific integrity, ethical standards, and attention to detail, ensuring that all information is reliable, unbiased, and compliant with regulatory guidelines.
Services
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Preparation and support of the Common Technical Document (CTD)
Module 2.4, 2.5, 4 and 5 compilation for the Non-Clinical and Clinical overviews in line with EMA guidelines.
Bioequivalence assessment
Evaluation and inclusion of results from bioequivalence studies in the Common Technical Document modules for generic applications.
Preclinical and Clinical evaluation
Literature search and review for the preclinical and clinical evaluation of active substances contained in the marketing authorization application.
Literature search and review
Provision of scientifc advice or documentation for Pharmacovigilance and other medical purposes.
Biowaiver documentation and justification
Preparation of Biowaiver report for regulatory approval to waive certain bioequivalence studies for generic drugs.
Preparation and translation of product information
Preparing the product’s information texts in accordance with EMA guidelines and regulations, and providing high-quality medical translations (English/Greek).