Quality Assurance

Our industry-experienced experts have implemented dozens of quality systems within the biopharmaceutical, pharmaceutical, medical device, and combination product industries. We assist with organizational activities, plans, policies, procedures, and processes and provide the resources to design, implement, and maintain a quality system that delivers quality, compliant drug products.

We develop and implement quality systems in accordance with:

  • Current Good Manufacturing Practices  (21 CFR 210 and 211, 600, 601, 610, 820 and 1271)
  • Combination Products GMPS (21 CFR 4)
  • Pharmaceutical Development (ICH Q8)
  • Risk Management (ICH Q9)
  • Quality Systems (ICH Q10)
  • Good Manufacturing Practices for Active Pharmaceutical Ingredients (ICH Q7A)
  • EU Good Manufacturing Practices (Eudralex Volume 4)
  • Australia’s PIC/S Guide to Good Manufacturing Practices

Establishing quality management systems excellence

Our team designs and implements quality system procedures and instructions in line with client objectives and the requirements of the leading regulatory bodies. Elements of our quality management system programs include the establishment and/or management of:

  • Document control system
  • Electronic document management system
  • Deviations and CAPA SOPs
  • External audit SOP
  • Performance of GMP and GLP audits
  • Establish phase-appropriate training SOP and program
  • Vendor qualification, audits, and materials management programs
  • Change control
  • Quality risk management (e.g., microbial control, quality risk assessment, etc.)
Internal & external audits

Whether preparing for and supporting an external GMP audit by a global regulator [pre-approval inspection (PAI), pre-licensing inspection (PLI)] or planning and executing an internal audit, our team offers comprehensive capabilities.

Global FDA/EMA remediation projects

Leveraging decades of experience, BioTechLogic supports comprehensive global inspection readiness remediation projects.

  • Quality plans for Six-System inspection readiness
  • Remediation team leadership
  • Conduct mock inspections
  • Provide remediation services for all GMP departments
  • Reorganization and establishment of a high-performance management team
  • On-site support and team augmentation
Combination products quality support

BioTechLogic assists companies by supporting the registration of drug-device combination products. BioTechLogic’s team can guide you through the matrix of requirements. The following are examples of services to help support combination products throughout product development and into commercialization:

  • Quality System Mapping and Quality Planning for products, gaps in the quality system, or transitions to new regulatory requirements
  • Establish new QMS in accordance with GMP for Combination Products (21 CFR Part 4)
  • Provide on and off-site quality system support including reviewing documentation, generation of system procedures and forms, corrective and/or preventive action recommendations, management review system and training

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Quality Assurance

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