DANNALAB

Terms & Conditions

Terms of service for DANNALAB analytical testing services, including scope of services, client responsibilities, and limitation of liability.

Scope of Services

DANNALAB B.V. provides analytical testing services including X-ray powder diffraction (XRPD), small-angle X-ray scattering (SAXS), X-ray reflectometry (XRR), and grazing incidence diffraction (GID) for pharmaceutical, biopharmaceutical, and medical device applications.

Our services are provided in accordance with:

  • Our documented quality management system
  • Applicable quality standards (cGMP, ISO 9001:2015)
  • Pharmacopeial methods where applicable (USP<941>, Ph.Eur<2.9.33>)
  • Client-specified or mutually agreed methodologies

Basis of Service — "As Is"

All analytical results, reports, and data are provided "AS IS" based on the samples received and analytical methods employed, without warranty of fitness for any particular purpose.

What This Means

  • Professional expertise applied: We apply appropriate scientific expertise and quality assurance to all projects
  • Results as measured: We report what we measure based on samples as received
  • Best knowledge and efforts: Analysis conducted with professional care and best efforts
  • No guarantee of outcomes: We cannot guarantee regulatory acceptance, patent grants, or specific business outcomes

Client Responsibilities

Clients are responsible for:

Method Suitability

Determining whether our analytical methods are appropriate and sufficient for your intended regulatory, quality control, or research applications. We provide technical guidance, but final suitability determination is your responsibility.

Sample Integrity & Representativeness

Ensuring samples are representative of the material to be characterized, properly prepared per our guidelines, and maintained with appropriate handling during shipping and storage.

Regulatory Decisions

All decisions regarding regulatory compliance, submissions to health authorities (FDA, EMA, etc.), and use of analytical data in regulatory filings. While our reports support submissions, we do not provide regulatory strategy advice.

Result Interpretation

Interpreting analytical results in the context of your specific product, manufacturing process, regulatory requirements, and quality specifications.

Business & Legal Decisions

All business decisions including product development strategies, patent filings, commercialization plans, and legal matters related to intellectual property.

Specification Setting

Establishing appropriate acceptance criteria, specifications, and quality standards for your products based on analytical capabilities and regulatory requirements.

Regulatory Acceptance

DANNALAB operates under current Good Manufacturing Practice (cGMP) with appropriate quality systems, certifications, and regulatory compliance. However, we do not guarantee acceptance of our analytical reports by any regulatory authority.

Important considerations:

  • Regulatory acceptance depends on many factors beyond analytical data quality
  • Each regulatory authority makes independent decisions
  • Submission strategy, context, and totality of data affect acceptance
  • Regulatory requirements evolve and vary by jurisdiction
  • We recommend consulting regulatory specialists for submission planning

Our commitment: We provide high-quality analytical data with appropriate documentation, QA oversight, and compliance with applicable standards. To date, our reports have been accepted by regulatory authorities worldwide, but we cannot guarantee future acceptance in any specific case.

Analytical Limitations & Detection Limits

All analytical methods have inherent limitations:

  • Detection limits (LOD): We cannot detect impurities, polymorphs, or phases below method-specific detection limits
  • Quantification limits (LOQ): Quantitative results below LOQ are estimates with higher uncertainty
  • Sample-dependent performance: Complex matrices, excipients, or interfering substances may affect method performance
  • Representativeness: Results apply to samples as received; we cannot verify sample representativeness of larger batches
  • Amorphous materials: XRPD provides limited information on non-crystalline substances

Where applicable, we provide LOD, LOQ, and method validation parameters to define analytical capabilities and limitations.

Limitation of Liability

Maximum Liability: DANNALAB's total liability for any claims arising from our analytical services shall not exceed the fees paid for the specific project giving rise to the claim.

Excluded Damages: In no event shall DANNALAB be liable for indirect, consequential, incidental, special, or punitive damages, including but not limited to:

  • Lost profits or business opportunities
  • Regulatory delays or rejections
  • Product recalls or market withdrawals
  • Development costs or time investments
  • Business interruption or reputational harm

This limitation applies regardless of the cause of action, whether in contract, tort, negligence, or otherwise, and even if DANNALAB has been advised of the possibility of such damages.

Sample Handling & Retention

Sample storage: Samples are stored under appropriate conditions according to our SOPs. We maintain unique sealed sample storage enabling reanalysis if needed.

Sample degradation: Despite best efforts to maintain sample integrity, we are not responsible for sample degradation, transformation, or changes that may occur during shipping, storage, handling, or analysis.

Retention period: Sample retention periods are established per project agreement and regulatory requirements. Extended archiving is available by arrangement.

Sample return: Samples can be returned upon request if sufficient material remains after analysis.

Confidentiality

DANNALAB maintains strict confidentiality for all client projects. We accept client NDAs and maintain comprehensive confidentiality protocols.

All project data, samples, and communications are treated as confidential unless otherwise agreed in writing.

Governing Law

These terms and conditions, and all services provided by DANNALAB B.V., shall be governed by and construed in accordance with the laws of the Netherlands.

Disputes: Any disputes arising from our services shall be subject to the exclusive jurisdiction of the courts of Enschede, the Netherlands.

Questions About These Terms

If you have questions about these terms and conditions, please contact us:

DANNALAB B.V.
Wethouder Beversstraat 185
7543 BK Enschede
The Netherlands

Email: info@dannalab.com
Phone: +31 (0)6 41 434 983

Last updated: November 2025