NEWS
KATEGORİDEKİ DİĞER YAZILAR
A Milestone in Regulatory Science: Nanolab Laboratory Group Reaffirms OECD GLP Compliance — Building a Bilingual, Globally Integrated Preclinical Platform
We are writing this with a deep sense of professional pride and scientific gratitude.
Following a rigorous two-day on-site inspection (21–22 October 2025) conducted by the Turkish Accreditation Agency (TÜRKAK) — Türkiye's national GLP monitoring authority and a recognised participant in the OECD Mutual Acceptance of Data (MAD) framework — Nanolab Laboratory Group, Edirne GLP Branch, has been issued a renewed Statement of OECD GLP Compliance (File No: AB-0021-IL, Revision 02, dated 12 March 2026), valid through 01 February 2027.
This is not merely a certificate on a wall. It is the tangible outcome of years of disciplined effort: building a test facility from the ground up that operates in full accordance with the OECD Principles of Good Laboratory Practice (as revised, 1997), EU Directives 2004/9/EC and 2004/10/EC, and the corresponding Turkish national regulation on GLP harmonisation.
WHAT THIS COMPLIANCE COVERS
Our GLP scope — verified and documented in the TÜRKAK Annex — now encompasses nine formally recognised areas of expertise:
▸ Physical-Chemical Testing ▸ Toxicity Studies ▸ Mutagenicity Studies ▸ Residue Studies ▸ Biosafety Studies ▸ Biocompatibility Studies ▸ Microbiological Tests ▸ Pharmacodynamic Studies ▸ Pharmacokinetic Studies
This breadth is deliberate. It reflects our commitment to serving as a comprehensive nonclinical testing facility capable of supporting the full spectrum of preclinical safety and efficacy evaluation — from early-stage physicochemical characterisation through pivotal toxicology, genotoxicity, biocompatibility (per ISO 10993 series), pharmacokinetic profiling, and pharmacodynamic assessment — all under a single, unified quality management system governed by GLP principles.
THE BILINGUAL ARCHITECTURE: A STRATEGIC IMPERATIVE
From the very beginning of our facility design and quality system development, we made a deliberate and, we believe, forward-thinking decision: to construct an entirely bilingual operational infrastructure — Turkish and English — running in parallel, not as an afterthought, but as a foundational architectural principle.
Why does this matter?
Turkish-language documentation is essential to satisfy all domestic regulatory requirements under the Turkish Ministry of Environment and Urbanisation's GLP regulation and to ensure seamless interaction with TÜRKAK inspectors, national sponsors, and local regulatory submissions to the Turkish Medicines and Medical Devices Agency (TİTCK).
English-language documentation, maintained at an equivalent level of regulatory rigour, enables us to accept and conduct studies commissioned by sponsors from any OECD member state and beyond — and to generate study reports, raw data packages, and final reports that are directly submittable to the FDA, EMA, PMDA, TGA, ANVISA, CDSCO, MFDS, and other global regulatory authorities without the friction, delay, or risk of post-hoc translation.
This is not a cosmetic choice. In a world where the Mutual Acceptance of Data (MAD) system exists precisely to eliminate redundant testing across national borders, the language in which your GLP data package is generated is a critical enabler — or a silent barrier — to true international data portability. We chose to eliminate that barrier from day one.
Every Standard Operating Procedure, every study plan, every amendment, every final report, every quality assurance statement — exists in both languages, maintained under version control, with regulatory equivalence assured.
OUR VISION: A ONE-STOP PRECLINICAL AND CLINICAL PLATFORM
The GLP compliance we have achieved is, in our strategic planning, the first pillar of a much larger edifice.
Our roadmap includes:
▸ Expanding our nonclinical testing capabilities to cover the full range of OECD Test Guidelines and ICH safety pharmacology, toxicokinetic, and genotoxicity requirements (ICH S1–S11 series, ICH M3(R2), ICH M7(R2))
▸ Integrating ISO 10993 biocompatibility testing as a dedicated service line — supporting medical device manufacturers and combination product developers with end-to-end biological evaluation under GLP conditions, aligned with the 2025 revision of ISO 10993-1
▸ Building toward GCP-compliant clinical trial capabilities — with the long-term objective of offering sponsors a seamless transition from preclinical safety assessment through Phase I/II clinical evaluation, all within a single, quality-assured organisational framework
▸ Establishing robust regulatory submission support — including CTD Module 2.4/2.6/4 authoring, IND/IMPD/NDA dossier compilation, and direct regulatory agency interaction support for multi-market filings
The goal is clear: to become a fully integrated Contract Research Organisation (CRO) that can take a sponsor's molecule or device from the bench through nonclinical evaluation, regulatory strategy, and into the clinic — under one roof, one quality system, and one point of accountability.
A WORD ON WHAT THIS TAKES
We want to be candid about something. Building a GLP-compliant test facility in a developing CRO landscape is not glamorous work. It is painstaking. It requires an obsessive attention to detail — in facility design, environmental monitoring, equipment qualification, personnel training, archive management, specimen handling, computerised system validation, and a hundred other operational elements that never make it into a brochure but are the difference between a facility that can withstand a regulatory inspection and one that cannot.
It requires a culture — not just a set of SOPs — where data integrity is non-negotiable, where deviations are reported and investigated rather than concealed, where the Quality Assurance Unit operates with genuine independence, and where every member of the team understands that the reliability of our data is ultimately a matter of patient safety.
That culture does not emerge from a certificate. The certificate emerges from that culture.
We have built that culture together — across every department, every role, every shift — and this renewed GLP compliance is its proof.
TO OUR CURRENT AND PROSPECTIVE SPONSORS
If you are a pharmaceutical, biotechnology, agrochemical, medical device, or cosmetic company seeking a GLP-compliant nonclinical testing partner with:
✔ OECD MAD-recognised GLP compliance across nine areas of expertise ✔ Full bilingual (Turkish–English) operational capability ✔ Capacity for toxicity, genotoxicity, biocompatibility, PK/PD, biosafety, and physicochemical testing ✔ A strategic roadmap toward integrated preclinical + clinical CRO services ✔ Direct experience with FDA, EMA, CDSCO, ANVISA, TGA, and MFDS regulatory expectations
— we invite you to reach out. We are ready to discuss how Nanolab can support your development programme with the scientific rigour and regulatory compliance your product — and your patients — deserve.
📧 [email protected] 🌐 https://www.nano-lab.com.tr/ 📞 +90 212 855 4810 📍 Edirne, Türkiye
Mr. Özkan Yıldırım Chief Executive Officer & General Manager Nanolab Laboratory Group
#GLP #GoodLaboratoryPractice #OECD #MAD #PreclinicalResearch #RegulatoryToxicology #CRO #Nonclinical #Biocompatibility #ISO10993 #ClinicalTrials #GCP #FDA #EMA #TURKAK #ContractResearch #DrugDevelopment #MedicalDevices #PatientSafety #Nanolab #Turkey #Türkiye
