- 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
|
