Solutions
Anabiotec provides analytical insight during CMC activities for your product development & filing, from pre-clinical to market. With more than 25 years of experience in analytical method development and validation we help you mitigating risk and accelerating timelines. Our experienced scientific project managers connect the dots in your projects and safeguard your milestones. We apply a hands-on and personalized approach, and contribute to solving complex analytical challenges across all stages of drug development.
Experience across diverse product matrices
A proven track record over decades of analytical excellence
Complex formulations & Mixtures
- Liposomal products
- Suspensions
- Low solubility products
- Microspheres & Derivatized products
- Peptide mixtures
Specially regulated substances
Regulatory-approved handling of
- Hormonal compounds (e.g. estrogens)
- Narcotic compounds
- Psychotropic substances
High potency compounds
- Capabilities up to OEL 5
- Chemotherapy (e.g. cytostatics)
- Pharmaceutical modality: Drug substance (API) or Drug Product
- Dosage forms: Tablets, liquids, capsules
- Biological materials: Whole blood, plasma, urine, CSF, cells and tissues
- Species: Human, mouse, rat, horse, rabbit, dog, e.a.
Your science-driven partner for compliant analytical solutions
Anabiotec delivers regulatory-compliant analytical solutions, combining deep scientific expertise with the operational agility required to meet your critical drug development timelines.
Quality
- GMP-certified (H/V/IMP)
- GCLP-compliant
- FAMPH/FDA-inspected
Scientific expertise
- Scientific project managers (SPOC/SME)
- Expert scientist team for development, characterization & investigations
Operational agility
- Pro-active planning focused on your milestones
- Flexible reporting
- In-house or client’s format for procedures/ protocol/reports
- Data input in LIMS of Client
Infrastructure
- State-of-the-art facilities
- Authorized for Biosafety Level 2+ (BSL-2+) operations