Email : info@gapsos.com
Contact : (321) 445-1969

Brief Bio of the CEO

Nepton Sheikh- Khoni: A Florida Resident--- USA-- and a Clinical/Medical Practitioner for more than 14 years. A medical doctor with adequate clinical training in internal medicine and oncology. More than 9 years of clinical development as well as pharmacovigilance and epidemiology. Worked as a clinical technician into a leading MD in the complexed structures of clinical development. A broad background in the Pharmaceutical industry in the areas of drug safety, pharmacovigilance, pharmacoepidemiology, and surveillance. Particular approaches via the following: Operations as well as ICSR/Aggregate reporting, Safety Reporting and Assessment Safety process, Joint Venture Development Opportunities, RISKMAP, REMS, NDA, BLA, data migration/reconciliation, and auditing process-certification in association to corporate compliance. Clinical Safety and developments efforts including but not limited to phases I-IV.

DSMB

A Data Monitoring Committee (DMC) is an autonomous collection of clinical professionals which monitors patient safety andefficacy data

CEC

The CEC identifies/chartered suspected events by systematic review of clinical; including biomarkers related to the events of interest,

SAC

According to the new draft Drug Safety Guidance for Industry, Biopharmaceutical and Devices companies are urged to consider utilizing Safety Assessment Committees

Risk Management Services

GAP begins a risk management program with classification and evaluation of risks related to the products.

QPPV

(QPPV) services for clients who are entering in the European Union (EU) market to ensure a strong administration of Marketing Authorization Holder's

SCP-TECHNOLOGY

SCP- Technology is a novel modality that provides enhanced solubility of chemotherapeutic agents; in addition to the class III- IV compounds,