Regulatory Scientific & Health Solutions (R-S-S) supports the biopharmaceutical industry using former regulatory experts with the added advantage of executing and delivering a number of key services including:

(i) statistical analyses and trial design for multiple disease areas (our experts have assessed in nearly every conceivable disease area), and phases of drug development.

(ii) Health economic modelling and HTA reimbursement across markets supporting Market Access needs, including PIMS , EAMS schemes and PRIME (EMA); Systematic Literature Review and Network Meta-Analyses for Reimbursement.

(iii) Regulatory consulting for FDA/EMA including response to questions and dossier preparation.

(iv) Data management services – specializing in early (Phase I-II), clinical pharmacology data management and analyses using EDC systems.