DANNALAB: Pharmaceutical XRPD & SAXS CRO Services

DANNALAB is located in the Netherlands, a beautiful country renowned for its tulips, windmills, and canals.
We specialize in X-ray characterization of pharmaceuticals and offer expert services in X-ray Powder Diffraction (XRPD) for small-molecule drugs, as well as Small Angle X-ray Scattering (SAXS) for biologics and biosimilars.

XRPD Services:

- cGMP XRPD characterization, including method development and validation
- Identification and quantification with LOD/LOQ's competetive to those achieved at synchrotron beamlines
- Quality control during batch release with a turnaround time of up to 48h
- Pharmaceutical patent-related services

SAXS services

- cGMP SAXS characterization including method development and validation (rarely available)
- Dedicated studies of drug delivery systems
- Reconstruction of biopolymers, peptides and virus structures

Compliance and Support

- Compliance: USP<941>,Ph.Eur<2.9.33>, cGMP adherence
- NDA: As-is acceptance for efficient collaboration
- Track Record: Till now, all our reports have been accepted by regulatory authorities worldwide
- Inspections: Facility access for transparency and trust
- Support: Same-day assistance, including regulatory inquiries
- Handling: Expertise in managing toxic, air-sensitive substances, and also in microquantities
- Archiving: Unique, indefinite storage of prepared samples for easy access

Additional Services

- On-demand synthesis of polymorpic forms
- Complimentary SAXS/XRPD beamline studies
- Complimentary Cryo-EM studies

Contact Us

- Evaluating the quality of raw materials

- Outsourcing quality control during batch release
- X-Ray analytical support for your R&D project
- In-depth physico-chemical characterization of drug substances or products
- Expertise related to X-Ray specifications in pharmaceutical patents
- Investigating deviations in your pharmaceutical production process
- Non-trivial studies

We welcome all inquiries and are here to support your pharmaceutical analysis needs.