Our dedicated project managers and subject-matter-experts have successfully developed and transferred a wide range of drug products and dosage forms, supporting diverse regulatory approvals (505 (b) (1), 505 (b) (2), ANDA). Groupe PARIMA can meet your product development and site-transfer needs. We offer turnkey solutions, and our experts in formulation development, scale-up process, analytical method development & validation and packaging, will see your products through initial development phases until completion of process validation. We can also support your pre-IND activities.
Type of products
| Form | Packaging |
| Semi-solid (cream, lotion, ointment, gels) | Tube, pump sprays, airless pumps, jars, bottles, syringe applicators, sachet, stick-packs |
| Liquid (oral, otic, nasal or topical) | Pump sprays, airless pumps, jars, bottles, syringe applicators, metered-dose sprays, sachet, stick-packs, towelettes |
| Suspension (oral, otic, nasal or topical) | Pump sprays, airless pumps, jars, bottles, syringe applicators, sachet, stick-packs, towelettes |
Critical work of providing your product with the desired characteristics to achieve the targeted safety and efficacy profile starts with the elaboration of an optimal formulation. To this end, we offer:
- De Novo formulation, deformulation or optimization of an existing formulation
- Quality by Design (QbD) and Design of Experiments (DoE)
- Technical transfer and scale-up (clinical, exhibit, commercial)
- Selection of packaging components
- Preparation of the complete data package for regulatory filing
Our expertise is focused on semi-solid, liquid and suspension dosage forms to ensure cutting-edge solutions to today’s drug development requirements. We offer:
- Small scale manufacturing and packaging for pre-clinical studies
- Supply of cGMP clinical material of Phases I to III
- Storage of products for future studies
- Product stability program
- Customized packaging and labeling
Our dedicated team of validation experts has successfully validated processes for a wide range of drug products. Our pre-commercial validation support includes:
- Manufacturing, holding, packaging and cleaning validation
- Procurement of materials
- Artwork and Serialization
- Product stability studies