PHARMACEUTICAL REGULATORY

Pharmaceutical Drugs

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

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