Experienced in global regulatory consulting

• National and international regulatory strategy and development for the biopharmaceutical, medical device, veterinary and biologics industries
• Regulatory submission (IND, CTA, NDA, CTD, eCTD, DMF, ANDA)
• Communicate, interact, and liaise with global regulatory agencies
• Regulatory intelligence [Rockville in US, Ely in UK]
• Comprehensive CTD and eCTD capabilities
• Thorough knowledge and practical advice relating to Clinical Trial Applications
• New EU pharmaceutical legislation
• Expert review of Chemistry and Manufacturing, Non-clinical and Clinical data
• Clinical Quality Assurance (GCP)
• Non-clinical
• Clinical Development Planning
• Auditing (GLP and GMP)
• Pharmacovigilance and safety