TALKING STRAIGHT

Regulatory Scope

  • General GMP Guide (21CFR Parts 110 and 111)
  • CMC (ICH Q1-Q4, Q6, Q7, Q11, M7)
  • Quality Assurance (FDA Process Validation Guidance; ICH Q8, Q10)
  • Risk-Based Approach (ICH Q9)
  • Documentation Format (ICH M4 and M8)
  • Facility Identification/Supply Chain Security (FDASIA)
  • Registration (21CFR207/21USC360)
  • GDUFA

Note: This list may change as the regulations evolve.

Focus Area

  • Chemistry, Manufacturing and Controls
  • Drug Master File Preparation and Submission
  • Establishment and Facility Registrations
  • Audit/Inspection Planning
  • Regulatory Correspondence

Description

Quality System Improvement

  • Perform On-Site Audit and Generate Audit Report
  • Quality Topics Training Lecture
  • Risk-Based Quality System Design
  • Manufacturing Process Validation
  • Quality Incidents/Customer Complaints
  • CAPA Implementation
  • Change Control Management
  • Product Life Cycle Management

Compliance

  • Prepare for and Help Host in US FDA Inspection
  • Prepare Inspectional Responses to FDA
  • FDA 483 Correction
  • Warning Letter Close-Out
  • DMF Deficiencies Response
  • Postapproval Changes
  • National Drug Labeling Registration
  • Establishment Registration
  • GDUFA Registration
  • DMF Submission/Update

Other Services

  • Document/SOPs Generation or Editing
  • Drug Master File Compilation or Editing
  • Manufacturing Batch Record Generation or Editing
  • Document Translations
  • US Agent/Contact Address

Service Type

General Consultation

Client will have a chance to ask questions on manufacturing control, quality assurance and regulatory issues in this one-hour general consultation session. It is also an opportunity to reach mutual understanding on how a Regular Service may be set up. Flat fee is applied before or at the consultation session.

Full Service

  • Project Package: include all above-described activities as it pertains to specific project (s). Inquire about service agreement and fee schedule.
  • Annual Service Package: full service includes all above-described activities as it’s pertained to all projects during the period of one service year. We recommend this type of service for the benefit to product lifecycle management. Inquire about service agreement and fee schedule.
  • More info

    Coming soon...