Services

Our Services

Rendered services are fully compliant with the current normative references:

  • cGMP of the US FDA  (21CFR Part 211 and Part 820), and related guidance documents.
  • ISO Standard ISO 9000, ISO 13485, ISO14971and ISO Standard defined on your Technical Files.
  • EU GMP Part I, II, III guidance and annexes.
  • Local GMP regulations on regulated markets, like, UK, Japan, Russia, Brazil, Korea,… 

Our services include interim quality management support, QMS development and  implementation activities, non-compliance remediation plan, supplier audits services, handling of Regulatory and/or customer inspections and a host of other QA / QC activities. These services include, but are not limited to, the following:

  • Strategic management consulting relative to your Quality Systems, QA/QC organization and quality budget and expenses.
  • Quality Management System (QMS) development, enhancement or optimization by Lean Six Sigma principles.
  • QMS alignment and Compliance with International Regulations and Standards. 
  • Facilitation and management of new ISO certification projects
  • Assistance in selecting an EU Notified Body
  • Regulatory/customer audit preparation: pre-audit training, mock inspection, representation during audits (pre-approval, routine, follow-up compliance, «for-cause»).
  •  Internal Compliance Audits (to your schedule, or independent “3rd party”)
  • Supplier audits (quality/ risk audit). Supplier qualification. Supplier rating programs.
  • Independent Supplier failure investigations and problem solving.
  • Handling of complex quality failure investigations in Media Fills, aseptic manufacturing process, recurrent deviations, OOS/OOT, sterility testing, environmental control,… and root cause identification.
  • Development, implementation and follow-up of remediation plans. 
  • Development of holistic action plans to audit findings (Warning letters, 483’s,…) or complex quality failure. 
  • Management of complex quality projects, like new facility authorization, new product introduction, tech transfer activities, parametric release, Data Integrity Compliance, manufacturing of sterile products, Continuous Process Verification,…
  • Optimization of Master Batch Records/ Device History Records (DHR)
  • Risk Management / Risk Assessment / FMEA – FMECA
  • Complaint Handling System
  • Acceptance Sampling and SPC methodologies

IQM-Consulting will tailor our work to your particular needs, and in support of your particular time-frame. We will structure our work-efforts in a way that makes the most sense for you:

  • Remote document review and draft revisions.
  • Single-event session (remote or on-site)
  • Strategy meetings (remote or on-site)
  • As-needed support (remote or on-site)
  • Project-specific support (remote or on-site)
  • Element-specific support (remote or on-site)