About DANNALAB
Specialized laboratory dedicated to serving pharmaceutical companies with X-Ray analytical services.
Pharma Industry Testing Laboratory
DANNALAB B.V. is a specialized testing laboratory focused exclusively on X‑ray characterization of pharmaceuticals and biopharmaceuticals. Since 2001, we have provided analytical services and expertise to support pharmaceutical research, development, and manufacturing.
We speak the language of industry: Timing, confidentiality, compliance, and quality assurance. We operate as an extension of your in‑house laboratory.
Industrial Focus
Dedicated testing laboratory serving pharma industry with established procedures, fast turnaround, and business-focused operations.
cGMP Operations
Quality systems, regulatory compliance, and inspection-ready documentation — not experimental research.
Confidentiality First
Client NDAs accepted as‑is. Strict confidentiality protocols. Your proprietary information is protected.
What We Offer Pharmaceutical Companies
For our customers, we offer facilities similar to those of a dedicated in‑house laboratory:
Predictable Timing & Delivery
- Committed turnaround times: 1-7 days standard, 24-48h for urgent
- Project schedules aligned with your development timelines
- Batch release testing with guaranteed CoA delivery dates
- Reliable availability and consistent capacity
Established Procedures
- Validated methods ready for immediate use
- SOPs for all operations — no experimental protocols
- QA oversight and independent review
- Regulatory-ready documentation as standard output
Business Confidentiality
- NDAs accepted as‑is in most cases — we sign your terms
- Secure data handling with controlled access
- No publication of your data or samples
- Chain‑of‑custody for sensitive materials
Method Development & Validation
- Collaborative development tailored to your product
- ICH‑compliant validation protocols
- Transfer packages with full documentation
- Expert troubleshooting and optimization
Fast Response & Support
- Same‑day response to technical inquiries
- Direct access to expert scientists
- Live support during method development
- Regulatory query assistance
cGMP Quality Systems
- Complete quality system with SOPs and CAPA
- Regular regulatory inspections (most recent: 2024)
- Instrument qualification (IQ/OQ/PQ)
- Advanced reporting and archiving
Why Companies Choose DANNALAB
Industrial focus: We provide the reliability, confidentiality, and established procedures that pharmaceutical development requires — with timing commitments, quality systems, and business focus built into everything we do.
Committed Delivery Dates
We operate on project schedules and industrial timelines. Your deadlines become our commitments.
Complete Confidentiality
Your proprietary data stays confidential. We never publish client work or use samples for external research.
Regulatory Documentation
Reports structured for regulatory submissions. CoAs, validation reports, and audit trails as standard deliverables.
Quality Assurance
QA review, SOPs, and cGMP compliance as standard — not optional extras.
Business Partnership
Commercial contracts, NDAs, invoicing, insurance — we operate as your trusted business partner.
Reliable Capacity
Year-round availability with dedicated capacity for your projects — no competing priorities.
Track Record & Experience
- Thousands of completed projects for pharmaceutical companies worldwide
- More than 20 years of successful operation with zero report rejection rate
- Multiple regulatory inspections passed with cGMP compliance confirmed
- Patents in X‑ray methodology — Dr. V.A. Kogan, PhD holds multiple patents in instrumentation and methods
Areas of Expertise
Small Molecule Pharmaceuticals
Polymorphism, crystallinity, quantification, method validation, batch release, stability
Biopharmaceuticals
Protein structure, aggregation, biologics stability, biosimilar characterization
Drug Delivery Systems
Liposomes, LNPs, nanoemulsions, vesicle characterization, formulation optimization
Medical Devices & Materials
Advanced X-ray techniques (XRR, GID, XRPD) for implants, coatings, stents, bio-materials
Patent Analysis
IP comparison, freedom-to-operate, patent specification development
Special Sample Types
Cytotoxics, air-sensitive, micro-quantities, liquid matrices, temperature-sensitive
Research & Development
While DANNALAB is an industrial testing laboratory, our expertise also contributes to the development of new X‑ray methodologies through collaboration with industry partners and research institutions.
Dr. V.A. Kogan, PhD has authored multiple patents in X‑ray methodology and instrumentation. DANNALAB serves as an expertise center for advancing pharmaceutical X‑ray characterization techniques.
Company Management
Dr. V.A. Kogan, PhD
CEO & Scientific Director
Founder of DANNALAB with 30+ years of experience in pharmaceutical X‑ray characterization. Multiple patents in X‑ray methodology and instrumentation.
Dr. I. van Nugteren, PhD
QA Manager
Responsible for quality assurance, regulatory compliance, and cGMP operations oversight.
Location
DANNALAB is based in Enschede, in the eastern part of the Netherlands, close to the German border. The location provides easy access for European clients while serving pharmaceutical companies worldwide.
Address:
Wethouder Beversstraat 185
7543 BK, Enschede
The Netherlands