At Theraproval we are committed to providing effective regulatory and product development consultancy.
Theraproval are delighted to offer you regulatory consultancy services whether your requirements are for high-level strategic advice or hands on regulatory document preparation & submission:
- Marketing authorisation applications
- Lifecycle maintenance
- Variations, renewals, PSURS
- SmPC/Labelling development
- Clinical trial design & Clinical trial regulatory support
- New CTAs & CTA maintenance
- DSURS
- Scientific advice
- Change of ownership/license transfer
- Quality assurance
- Grant applications
- Innovative regulatory strategy development for:
- Small & large molecule drug products
- Medical devices
- Combination products
- Software as a medical device
- Sterile products
- Development of regulatory strategy documents
- Act as regulatory Liaison (GRL or EU RL)
- Independent & confidential due diligence (Investment, Acquisition or competitive)
Our services can be provided on ad hoc, temporary, long term or discrete project basis.
