Email :
Contact : (321) 445-1969

Who are we?

We are an independent A-rated rescue organization empowered by the black belts of the biopharma. We are a focused disaster and rescue relief group of seasoned biopharmaceuticals professionals: Concentrating on major regulatory, clinical, medical, and/or operational failures. We resolve significant findings, primary 483's, article 20's, consent decrees, the study holds, or safety/clinical- operational halts; no problem, contact us. We manage the end- to- end rescue mission on any significant challenges. We offer immediate pipeline expansions in case of failed trials, ramp up expansions, as needed, accrual boosting measures, as well as other boosting efforts to save the day. We are not just a group of consultants; we are a team of operatives.

Strategic Consulting focused entirely on at-risk programs in the industry. Our clients are uniquely selected. Our leading staff colleagues are uniquely trained and skilled to execute the most challenging tasks at the toughest times of any organizations. The best and brightest subject matter experts (SME), on-call 24/7.
For questions Please contact us.

What are our services?

Your success is our priority.
We can deliver what we promise!


We are the real deal AI. While Oracle speaks of open data and cloud systems to produce patient matching algorithm for clinical trials, our AI speaks to HEOR, Benefit:risk ratio, standard of care and the site’s available space to match the most patients for the best sites all at the same time. That means less pain in providing the site feasibility and man the inclusion/exclusion criteria. No one is as smart as we are. Take it to to the bank, now. Let us slash millions from your clinical development budget by being smart not to cut corners by “offshore” outsourcing empty promises of the multinational corporations. We know oncology, Immune Oncology, clinical trials and drug safety in a complete GXP environment. Be accountable to the patients. Use our AI- empowering capabilities in oncology clinical trials development.


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.

The A-Rated, end- to- end, Rescue Organization in biopharmaceuticals/devices. We resolve, mitigate and mediate your major regulatory, clinical, safety and manufacturing findings by FDA, EMA, and other health authorities(HA).

We manage all your challenges by our seasoned, thoughtful, and comprehensive oversight.

Call US before its too late!
We mediate, mitigate, and moderate your significant challenges in biopharmaceuticals/ devices: Pre- clinical, post- marketing and its end- to- end lifecycle management.


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


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

Risk Management Services

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


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


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