The development of new pharmaceutical drugs is accelerating at a rapid pace. Our team can guide your firm through the Pharmaceutical Regulatory regulations, review processes, quality controls and clinical trial and evaluation. We help you implement effective processes for your Pharmaceutical Regulatory Affairs in the early stages of the product development process, leaving you well positioned for sustained success.
We help you implement effective compliance processes in the early stages of the product development process, leaving you well positioned for sustained success.
Our services include: product and device compatibility, pharmacology assessment, FDA product submission and compliance, and international regulatory requirements.
Experience & Capabilities
FDA Compliance Consulting
Project Management
FDA 483 / Warning Letter
Consent Decrees
Systems Monitoring
GXP Training
Product Submissions
Due Diligence
Product Reviews
Registration & Listing
Audits
Gap Analysis
Regulatory Strategies
Inspection Preparation
GMP Services
GCP Services
FDA Submissions
Clinical Development
Nonclinical Development
Risk Based Assessment
Combination Products
Staff Augmentation
Electronic Publishing
Program Design