Dr. Uwe Totzke
TOTZKE & DREHER SCIENTIFIC SA
Skills And Services Offered:
Holding University degrees in Biology (PhD) and Pharmaceutical Medicine along with EMWA foundation and advanced level certificates, I have a thorough understanding of drug development and life cycle management which is backed by sound knowledge in statistics and therapeutic areas. Ten years of experience in clinical research have qualified me as a reliable partner for pharma and biotech companies, CROs, as well as academic societies and researchers.
My services comprise the:
- writing from scratch
- updating and editing
- reviewing and quality control
- submission-ready formatting
of any kind of life science document;
- whether for Regulatory Affairs, Medical Communication or Marketing
- for any indication and at any stage of a product’s life cycle
- in compliance with Clients’ SOPs, templates, and applicable guidelines.
Services also include consultancy, data management, and statistical analyses, if requested.
- Briefing Books in preparation of advisory meetings with Health Authorities
- CTDs for new drug applications (including orphan indications) or label changes (type-II variations, OTC-switches)
- Labelling information (SmPC, CDS, and PIL), including in-depth analyses and responses to questions raised by Health Authorities
- Clinical Expert Statements for marketing authorisation renewals
- IBs; IMPDs and INDs to start clinical trials in Europe and the USA, respectively
- Study protocols, reports, and corresponding synopses for trial registries
- RMPs, PIPs, and safety reports (e.g. PSURs) to apply for and maintain marketing authorisation
- Bioanalytical method validation reports
- Internal strategic documents, due diligence dossiers, and medical reviews
Medical Communication & Marketing
- Publications according to journal requirements, GPP, and the reporting guidelines relevant to the type of study
- Conference abstracts and slide decks
- Marketing brochures
As Associate Director of a global clinical development unit in an international pharmaceutical company, I was in charge of designing clinical trials on the cutting edge and routinely met with health authorities, clinical experts, and key opinion leaders. I authored global standard operating procedures on the creation of study concepts, protocols, and clinical development plans. Before joining the pharmaceutical industry, I built from scratch a team of high-calibre scientific and regulatory experts within a specialty CRO. I personally contributed to worldwide over 50 regulatory submissions incl. IND, NDA, type-II variation, and reclassification dossiers for a variety of indications and drugs, ranging from those with orphan status to those of well-established use. I have also continuously been involved in investigator-initiated trials and in academic research projects granting me the authorship of several publications.