QP and Quality Services
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Pharmaceutical Solutions is a privately owned Limited Company, established in January 1997.
We provide a wide range of QP, QA, GMP and regulatory services to the pharmaceutical and veterinary industries.
Representatives of the company are Qualified Persons (under directives 2001/83/EC and 2001/20/EC) able to provide general support and/or batch certification for a range of products for investigational (clinical trials) or commercial use, including oral, sterile and topical dosage forms as well as medical gases.
The company also offers auditing services, on site or remote quality/technical support and Quality System development.
Provision of Qualified Person Resource:
- Review, certification and release of all major dosage forms
- QP-Certification, release or advice
- Experience in QP release of medicinal products imported from 3rd countries
- General QP oversight and support
Investigational Medicinal Product (Clinical Trial Supplies) Expertise:
- Phase I to IV trial support
- Importing from non-EU countries
- Experience in the certification of investigational medicinal products imported from 3rd countries
Facility Auditing / Supplier Management:
- Active pharmaceutical ingredient (API) manufacturers
- Excipient and component suppliers
- Contract manufacturing, packaging or testing facilities
- Assistance with general contract manufacturing sourcing
Facility preparation & readiness, in support of:
- Gaining new manufacturing authorisations / product license approvals
- Routine regulatory inspections
- Product license variations
- Self inspections, customer audits and corporate audits
Sterile product expertise:
- Including blow-fill-seal technology
- Facility, process pipework and vessel design
- Equipment assessment and specification
- Design and Documentation of Quality Systems
- Validation Support (Equipment and Processes)
- Project Management
- Pharmaceutical Solutions Ltd
Qualified Person (QP) Services, EUQP, QPService, Pharmsol, Pharmaceutical Solutions Ltd.