Pharmaceutical Development service
Solural Pharma offer Pharmaceutical Development service to our customers.
We have a strong record of supporting pharmaceutical companies in a variety of services both in a consulting role and as the pharmaceutical development partner undertaking all CMC development activities. We help our customers to assure that work is done in a coordinated and cost-effective way.
We support our customers with expert service and advice within:
- Formulation Development to achieve products with unique profiles
- Analytical Development and validation of QC methods to assure the quality of the products
- ICH stability testing according to regulatory guidelines to establish shelf life of products
- GMP Manufacturing of oral and dermal products in our GMP approved suites
- Technology transfer and support of scale-up activities
- Primary and secondary packaging and labelling of Investigational Medicinal Products
- QA, QC and QP release of Investigational New Products.
- Generating the CMC part of e.g. IMPDs, INDs and other regulatory documents
- Project Management and management of third-party providers
Furthermore, we help companies to protect their products by improving existing products to allow for
completely new properties/use and patent coverage. For these projects, we encourage for a discussion of the possibilities with our pharmaceutical scientific staff.