Pharmaceutical services from development to analysis.

We offer end-to-end solutions for pharmaceutical product development and registration:

1. Discovery and formulation
2. Deformulation – reverse engineering of generic products
3. Forced degradation and stability studies
4. Preclinical research
5. Clinical research
6. Registration dossier preparation

Our product registration services include:

1. Verification of product classification
2. Scientific assessment
3. Review and completion of required documents
4. Preparation of the dossier
5. Dossier submission to the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Product out-licensing

We also provide out-licensing services for developed medicinal products. For more detailed information, please contact us.

Download full product list (PDF)

Quality-control testing

We perform quality-control testing of raw materials and finished products in accordance with Ph. Eur. and USP standards, as well as in-house methods and requirements. Our services include:

1. Identification testing
2. Assay determination
3. Related substances and degradation testing
4. Preservative analysis
5. Dissolution and disintegration testing
6. Franz diffusion cell tests
7. Rheological studies
8. Aerodynamic particle size distribution (Next Generation Impactor)
9. Water determination
10. Melting-point determination
11. Stability testing according to ICH/EMA guidelines (controlled conditions 25°C / 60% RH, 30°C / 65% RH, 40°C / 75% RH)
12. Photostability testing
13. Impurity synthesis, isolation, identification and qualification (IR, NMR, MS)

Analytical techniques

1. High-performance liquid chromatography (HPLC) and ultra-high-performance liquid chromatography (UHPLC) with UV/Vis (DAD), refractive index (RI) and fluorescence detection
2. UV/Vis spectrophotometry

Analytical method development, validation and transfer

We specialise in analytical method development, validation and transfer (including methods for assay, related substances and dissolution testing). Methods are validated through laboratory studies to ensure that they meet the requirements of their intended analytical applications. All work is conducted in accordance with ICH guidelines:

1. Q2 (R1) Validation of analytical procedures: text and methodology
2. Q3A(R2) – Impurities in New Drug Substances
3. Q3B(R2) – Impurities in New Drug Products

Developed and validated methods can then be transferred to customers’ laboratories. At every stage, we provide the relevant quality documentation.

We provide R&D services for pharmaceutical formulations.

For the dosage forms listed below, our R&D services include:

1. Compatibility studies
2. Formulation development
3. Solubility studies
4. Discriminatory power determination
5. Manufacturing process development

We provide contract manufacturing services for pilot and full-scale batches of medicinal products, including:

1. Process transfer and adaptation
2. Manufacture of various solid, semi-solid and liquid dosage forms
3. Packaging, including blister packs and bottle filling

Our manufacturing process services include:

1. Manufacturing process development
2. Optimisation of the manufacturing process
3. Manufacturing process validation
4. Troubleshooting
5. Scale-up activities

Dosage forms and technologies

We manufacture a range of dosage forms using modern technologies.

Solid dosage forms:

1. Granules
2. Powders
3. Pellets
4. Tablets
5. Lozenges
6. Hard capsules

Semi-solid dosage forms:

1. Ointments
2. Gels

Liquid dosage forms:

1. Solutions
2. Suspensions
3. Syrups
4. Ear, oral and nasal drops

Technologies:

1. Wet or dry granulation
2. Spheronisation
3. Extrusion
4. Coating
5. Homogenisation

We provide a wide range of protein testing services. For custom assignments, please contact us.

1. Recombinant protein expression and purification
2. Protein formulation development
3. Protein aggregation assay development
4. Stability testing in different matrices
5. Analytical assay development