Life science QA/RA services bv / CPDS lean GMP

Over Life science QA/RA services bv / CPDS lean GMP

Be the Best and Save Big. Combination Products Device Specialists

Our approach is best described as customized and focused on meeting your specific needs. Key principles include:

· Collaborative Effort: Full support from management, involving the leadership team, site manager and CEO.

· Integrated Solutions: Seamlessly combining pharma and devices.

· Quality Focus: Prioritizing quality, with process performance following naturally.

· Proven Systems: Compliant, robust, effective and efficient systems.

· Experience and Service: Delivered with extensive experience and dedicated service.

· Results-Driven Quality Systems: Designed to bring tangible results for you.

Many service organizations excel in designing new products, usability studies and clinical studies. However, we aim to be the premier choice for global Quality Systems design and EU submissions.

Our Services Include:

· QMSR (13485:2016) Transition: Focused on process-based system design and risk management optimization.

· Careful Approach: Ensuring a smooth transition by not changing too many items at once. Training your staff to make informed choices and explain the system to any inspector.

Most pharmaceutical companies use quality systems because it is a requirement. Initially, GMP did not start as a quality system, but later extensions have made it more system-like. The upcoming QMSR change (including 14971:2019) requires 100% quality system management, making it time to reconsider your current QMS by also making it LEAN.

Our Process:

· First Contact: Whether remote or on-site, it all starts with the initial contact. Let our experience guide you.

Most current pharma systems we have evaluated are an uphill struggle with many deviations and CAPA's. This effort could be better used for rethinking and redesigning your QMS processes. It is time to experience the benefits of well-designed quality systems—from uphill to downhill.

Let us evaluate your current QMS and explore a more efficient future.

Trefwoorden

• Audit Management
• Auditing
• Devices
• Eu Regulations
• Inspection
• Inspection Ready
• Laboratories
• Lean Gmp
• Pharma
• Process Audits
• Qmsr
• Quality Manual
• Risk Management
• Technical Files
• Veterinairy

Adres

• Hoofdkantoor

  Buurt IV no 241156BH MarkenNoord-Holland, Nederland

Team per functiegebied

Gebaseerd op 2 openbare functieprofielen, stand van 4 september 2026.

• Consulting / Advisory1
• Operations1