wellcome to the website of
dr shushil choubey
" integration of scientific
knowledge to bring quick,
ethical  solution for
improvement of health"
"finding means to reduce
pain and suffering of the
living world"
"a nice green harmonious earth, a clean blue sky, a clean ocean, a freely-flowing river"

"a safe earth; with abundant food, shelter, medicine and care for all"

Visit My Personal Website: http://www.drschoubey.net/dr-shushil-choubey
For More Infromation Visit
Business and Finance
  • Rational and Development Cost
  • Project Planning and Management
  • Budgeting and Finance

Clinical Research
  • Pharmacokinetics - Bioequivalence, Bioavailbility, Drug Interaction, Drug Metabolism Studies - Protocol Development
    and Operation
  • Planning First In Human Studies - Protocol Development and Operation
  • Dose Ranging Studies - Protocol Development and Operation
  • Exploratory Clinical Trials - Phase-2a/b - Protocol Development and Operation
  • Confirmatory Clinical Trials - Phase-3 - Protocol Development and Operation
  • Post Marketing Studies - Phase-4, Marketing and Investigator Initiated Trials

Pre-Clinical Research
  • Pre-Clinical Toxicity - Defining Requirements, Planning, Execution  and Report
  • In-vitro Testing - Defining Requirements, Planning, Execution  and Report
  • Dissolution Test Methods - In-vitro In-vivo Co-relation
  • Drug Impurity - Defining Requirements, Safety Definitions for Identification, Reporting and Qualification

Regulatory
  • Regulatory Guidance - Pre-Clinical, Clinical and CMC
  • Safety Reporting Guidance - Investigational Products and Marketed Product
  • Regulatory Dossiers - Evaluation, Review and Writing
  • Harmonization of Local Regulation with ICH and Company  / Institutional Policies
  • Registration and Renewal of Registration of Products with Ministry of Health in Different Countries - Drug and Device
  • Policies and Import and Export of Drugs
  • Ethical Guidelines for Research and Setting up of Institutional Review Board and Independent Ethics Committee
  • Legal, Drug Pricing and Regulatory Consultation

Patent, Legal & Regulatory, Drug Price Support
  • Ethical Guidelines for Research
  • Legal, Drug Pricing and Regulatory Consultation
  • Regulatory Guidance
  • Complete CDT - Evaluation and, Writing
  • Harmonization of Local Regulation with ICH

Medical Affairs Support
  • Medical Information
  • Scientific and Medical Training
  • Promotional Material Preparation, Review and Approval

Research Writing
  • SOP - Regulatory, Clinical Trial (Sponsor's, Investigator's, CRO's), Bioequivalence and Bioavailability SOP,
    Pharmacovigilence SOP
  • Protocol and Case Report Form - Clinical Trial, Bioequivalence and Bioavailability, Protocols for NCE (including first
    in human)
  • Regulatory Dossier - IND, NDA, CTD, Schedule-Y
  • Safety - PSUR
  • Scientific and Medical Manuscript

For further information you are requested to contact : Dr. Shushil Choubey
Services:                                                                With My Limited Expertise and Experience I Can Offer To Help You With Any Or All Of The Functions