GMP Consulting
From scratch
From scratch
to GMP certification.
Facility setup, qualification and a complete QMS — built from the ground up.
Equinox GMP Consulting
Quality systems, built for Biotechnology and Pharmaceutical Facilities.
End-to-end GMP & quality consulting for R&D, QC and manufacturing facilities.
- EU GMP
- PIC/S
- TİTCK
- FDA
- EMA
- WHO
20+years in pharmaceutical & biotech QA
~300equipment & utilities qualified
3countries of international projects
GMP Lead AuditorExemplar Global certified
One partner. The whole path to GMP.
From the first layout drawing to a passed inspection — consulting, audits and training, alone or combined.
Know where you stand.
System-based audits, mock inspections and vendor qualification.
Teams that get it right.
GMP-focused programs tailored to your team and maturity level.
Sectors We Support.
- 01 Pharmaceutical GMP Manufacturing Facilities
- 02 Biotech GMP Manufacturing Facilities
- 03 CMOs
- 04 Emerging Start-ups & Spin-offs
- 05 University Research Centers
- 06 Tech Transfer Offices
How a project runs
From first drawing
From first drawing
to GMP certificate.
- Step 1 Design Layouts, cleanroom grades and personnel, material and waste flows.
- Step 2 Commissioning & Qualification Equipment, utilities and computerized systems, qualified.
- Step 3 Quality System SMF, CCS, SOPs, BMRs and risk management built from scratch.
- Step 4 Mock Audit A realistic inspection before the real one.
- Step 5 GMP Certification Walk into the inspection prepared, and pass.
Where I bring depth.
Two decades of hands-on work across the systems that matter most in biotech manufacturing.
Biologics
Quality systems for biotechnology R&D, QC and manufacturing.
Vaccines
VLP vaccine production, Phase 1 & Phase 2.
Bioreactor & TFF
FAT of bioreactor, TFF and MFCS systems.
Cleanrooms & CCS
Grades, flows and contamination control strategy.
Critical utilities
HVAC, PW, WFI and gas distribution qualification.
Computerized systems
BMS, SCADA, MFCS and Empower validation.
Selected work
Projects that shaped the practice.
Vaccine
VLP COVID-19 vaccine production
Phase 1 & Phase 2 manufacturing — recognised with a Regulatory & GMP Compliance Project Award.
Germany
Bioreactor, TFF & MFCS FAT
Factory acceptance testing of upstream and downstream process systems.
Korea
Technology transfer
Transfer of process and analytical know-how between sites.
About me
Cavidan Şentürk
Over 20 years as a Quality Assurance Manager and Qualified Person in pharmaceutical and biotechnology — designing and building complete quality systems from scratch for manufacturing facilities and QC laboratories.
- VLP COVID-19 vaccine, Phase 1 & 2Project award
- Bioreactor, TFF & MFCS FATGermany
- Technology transferKorea
- GMP Lead Auditor, Exemplar Global2022
Ready for your next inspection?
Let's talk about your facility, your timeline and where your quality system stands today.