Looking for partner for the development and manufacturing of medicinal D-vitamin (cholecalciferol).
Looking for partner (Europe preferred) for the development, as well as contract manufacturing of generic medicinal D-vitamin (cholecalciferol). The dosage form should be soft gelatin capsules. The preferred strengths are 4000.
Regarding the product development, we need the full development from formulation development of soft gelatin capsules , preliminary stab studies / stress tests, analytical method development and validation, manufacturing of pilot and validation batches and of course the corresponding documentation to EU-CTD dossier (modules 2.3 and 3). We also want CDMO to source API.
Also ready dossiers (with MA in EU of ready-to-file) are considered.
More information on the project and the reference product on request.
You might also be interested in
Requests by service category
- Academic collaboration
- Contract manufacturing, filling and packaging
- Pharmaceutical process development and validation
- Formulation development and drug delivery
- GMP audit services
- GLP services
- GCP audit services
- Quality management services
- Certification services
- Pre-clinical development and testing, pre-clinical CRO
- Clinical development and testing, clinical CRO
- Analytical laboratory and testing services
- Material testing
- eData - IT - software
- Regulatory services - CMC writing - medical writing
- Pharmacovigilance and QPPV services
- Consulting - strategy and development
- Legal counselling
- Translation services (medical, clinical, pharmaceutical)
- Warehousing, storage, sampling, logistics and transport
- Marketing, Sales, PR and communication
- Training and education
- Partnering/collaboration for drug dossiers, patents, drug candidates, medical technology
- Sourcing of APIs, Excipients, Intermediates, bulk drugs
Requests by regionRequests by specialty
Looking for special service?
Don't spend time on search!
Get applications from providers For Free