Endocrinology, Gynaecology and Uronephrology

Indications include

• Cushing’s syndrome
• Chronic Kidney Disease
• Urinary incontinence
• Infertility
• Vulvovaginitis

Recent assignments

• Prepare a high level regulatory strategy for an IVD to be marketed in the US and EU markets
• Design a development strategy for a biosimilar combination product, review stability and release testing specifications
• Facilitate a regulatory advisory panel to discuss a Phase 3 compound under development
• Perform a clinical, nonclinical and CMC regulatory due diligence
• Provide pharmacovigilance services for a MAA including Pre MAA, MAA evaluation and post-marketing services