プロフィール詳細

プロジェクトを作成

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Sandhya G.に依頼

United States

Strategic Pharmaceutical industry expert with 25+ years of experience in R&D & Regulatory affairs

プロフィール概要

DEVELOPED, FILED AND LAUNCHED OVER 100 PRESCRIPTION PRODUCTS, CORE COMPETENCIES INCLUDE - CROSS-FUNCTIONAL TEAM LEADERSHIP  CMC (FORMULATION & PROCESS DEVELOPMENT , SCALE-UP & TECHNOLOGY TRANSFER , ANALYTICAL METHOD DEVELOPMENT & VALIDATION)  CLINICAL TRIALS AND BIOEQUIVALENCE STUDIES REGULATORY AFFAIRS  PROJECT MANAGEMENT  IN VITRO PERMEATION TESTING  IN VITRO RELEASE TESTING  FDA MEETINGS  IND, PHASE I, II & III  LABORATORY SETUP DESIGN & INFRASTRUCTURE  ORGANIZATION BUILD UP  NEW PRODUCT LAUNCH  IP DEVELOPMENT  SMALL AND LARGE MOLECULES PROTEINS, PEPTIDES  CYTOTOXIC POTENT COMPOUNDS  PRODRUG  DRUG DEVICE COMBINATION

専門分野

• ★ Drug Development
• ★ Drug Formulation
• ★ Pharmaceutical Regulatory Affairs
• ☆ Zoology
• ☆ Animal Science
• ☆ Small Molecule Drug Development
• ☆ Drug Substance Characterization
• ☆ Drug Stability Testing
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Drug Efficacy Testing
• ☆ Bioavailability
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Reverse Engineering
• ☆ Regulatory Writing
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Technical & Scientific Writing
• ☆ Experimental Protocols
• ☆ SOP & Protocol Writing
• ☆ Science Communication

サービス

• Writing
• Consulting
• Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Recipe Development, Deformulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Prototyping, Reverse Engineering

職務経験

Principal

SG Pharma Consulting

3月 2023 - 現在

Principal & Managing partner

SG Pharma Consulting

3月 2023 - 現在

学歴

Ms. Pharmacy - Pharmaceutics & Drug Delivery

Faculty of Pharmacy, Jamia Hamdard

6月 1994 - 7月 1996

Masters Pharmacy (Pharmaceutics )

Faculty of Pharmacy

6月 1994 - 7月 1996

B. Pharmacy

Delhi Institute of Pharmaceutical Sciences & Research

8月 1990 - 5月 1994

認定資格

• AAPS

  AAPS

  1月 2026 - 12月 2026

出版物

PATENT

Sandhya Goyal (2012). US Patent 8,158,319. USPTO.

Sandhya Goyal (2011). US Patent 8,012,498. USPTO.

Sandhya Goyal (2000). US Patent 6,565,877. USPTO.