SERVICES

Domestic & International Services By Product Development Process

PRODUCT MARKETING OPPORTUNITIES

Strategic Business and Product Planning
Feasibility Pre-IND
Market Intelligence
Market Research
Product Acquisitions & Licensing
Product Development Alliances
Program Evaluation & Coordination
Outside Project Funding
Non-Clinical and Technology Evaluation

PROJECT MANAGEMENT

Project Identification & Evaluation
Project Feasibility
Pre-IND Meeting Package
Prepare and submit IND
Proof of Concept Studies
Pilot/Pivotal Studies
Regulatory Path Development
Clinical Protocol Development
Clinical Pharmacological Review
Clinical Documentation & Report Development
Statistical Design for Protocols
CRO Quotation Management & Selection
Project Tracking & Oversight
Safety Evaluations Literature
Biostatistical Analysis
Investigator Meeting Set-up and Management

SUBMISSION PREPARATION

Regulatory Submission and Preparation Review and Coordinate with FDA for: Pre-IND Preparation
Pre and Post IND Meetings
IRBs and Ethical Committees
ANDAs
INDs
Bio INDs
CBE30
PAS
NCEs
505(b)(2) NDA
BLAs
DMFs 
eCTD and CTD Preparation
Non-Clinical & Toxicology Review
CMC Preparation & Review
Medical Writing

AUDITS

Site Quality Audits
Site Monitoring
Biotatistical Analysis
GLP Audits
cGCP Audits
CMC Reviews
GMP Inspections
QA Training

TECHNOLOGY TRANSFER

Research and Review Intellectual Property Rights
Regulatory Review
Agreement Negotiations
Market Penetration Analysis
Trade & Government Relations
Importation and Approval of Foreign Products