Regulatory Expertise Supporting Pharmaceutical Programmes
SpectrumX has internal regulatory and quality expertise supporting pharmaceutical development, manufacturing and supply.
Regulatory Services
- Regulatory strategy
- Regulatory documentation
- Product development support
- Dossier preparation
- Regulatory submissions
- Licence and variation support
- Regulatory compliance assessment
- Pharmacovigilance support where applicable
- QP/quality oversight
- Support for unlicensed medicines/Specials programmes
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.