Quality & Regulatory Expertise
SpectrumX operates within pharmaceutical quality and regulatory frameworks supporting manufacturing, development and supply-chain activities.
MHRA — Licensed Pharmaceutical Manufacturing
SpectrumX operates an MHRA-licensed pharmaceutical manufacturing site specialising in the manufacture of unlicensed medicines within the scope of its applicable authorisation.
GMP — Good Manufacturing Practice
Pharmaceutical manufacturing operations are performed under applicable GMP requirements and within the site's Pharmaceutical Quality System.
- Pharmaceutical manufacturing
- Quality control and assurance
- Validation
- Qualification
- Deviation and CAPA management
- Change control
- Supplier qualification
- Batch release/QP oversight as applicable
WDA(H) — Wholesale Distribution Authorisation (Human)
SpectrumX holds a WDA(H), supporting the procurement, storage and distribution of medicinal products within the authorised scope.
GDP — Good Distribution Practice
Distribution activities are managed within applicable GDP requirements.
Controlled Drugs — Authorised Activities & Secure Infrastructure
SpectrumX maintains appropriate infrastructure and enhanced security controls to support Controlled Drug activities, including dedicated secure storage and controlled-access systems.
Looking for a Sterile Pharmaceutical Manufacturing Partner?
Whether you are developing a new product, transferring an existing programme, preparing for scale-up or looking for a long-term manufacturing partner, speak to SpectrumX about your requirements.