Regulatory Affairs

BIOLOGICS, BIOSIMILARS, CELLULAR AND GENE THERAPIES, ORPHANS

Regulatory authority liaison to EMA or FDA

Scientific Advice and Protocol Assistance from CHMP/EMA

Scientific Advice and Protocol Assistance from CHMP/EMA; SAWP/CHMP/EMA meetings

Rehearsing for FDA meetings; managing FDA meetings

PDUFA Type A, B, C or BsUFA US FDA meetings and NDA/BLA presubmission FDA meetings, MAA presubmission EU EMA meetings, MAA presubmission EU Rapporteur/Co-rapporteur meetings, Rapporteur/Co-rapporteur D120 and D180 EU Clarification meetings

INTERACT FDA/CBER meetings

Presubmission evaluation of technical data (chemistry/manufacturing, preclinical, clinical, labeling)

Determination of regulatory and legal status

Obtaining Small and medium-sized enterprise (SME) status, Orphan Drugs designation

Determination of regulatory strategy for planning, manufacturing, preclinical and clinical development

Expert reports; quality overall summary, non-clinical and clinical overviews and summaries

Paediatric Investigational Plans (PIPs)

Risk Management Plans (RMPs)

Product information: EU SmPC, PL, Labels; US PI, Labels,

Document preparation including marketing authorisation applications MAAs for drugs

Submission of responses and follow-up  to EMA MAA list of D120 and D180 Deficiency Questions or to FDA NDA/BLA/ABLA Disciplinary letters

Chemistry/manufacturing, preclinical and clinical consultations, technical reviews and writing