Services

CTD modules 2.4, 2.5, 2.6 and 2.7

Trial reports and other scientific material generated by the sponsor will be evaluated and properly presented in the respective modules. I will take care to identify and integrate appropriate publications which support the work of the sponsor and also provide a critical assessment of the drug proposed for approval. The aim is the creation of a dossier compliant to the actual ICH- GCP directives. The European Note for Guidance in a determined field of indication will be observed and strategically interpreted to achieve registration.

I have successfully managed projects in the following fields:

• Anti-infectives
• Antihypertensives
• Anti-anginals
• Analgesics
• Antiallergics
• NSAIDS
• Biosimilars
• Benign Prostate Hyperplasia
• Endocrinology
• Diabetes
• Urinary Incontinence
• Anticancer drugs
• Antipsychotics/Tranquillizer/Antidepressants

Handling of deficiency letters

Consultancy and co-operation in project teams / drug development teams

with the focus on Clinical Pharmacology, Pharmacology and Toxicology relating to the future registration of the product candidate.

Development and creation of dossiers for Scientific Advice, participation in discussions with the regulatory authorities, presentation, wrap-up