Although there is no guarantee the traffic light will always go green, Two Hats Regulatory Science GbR aims to help increase the chance of a green light for your:
- Post Approval variations to Marketing Authorisations
- European National, Centralised/Decentralised/MRP, WHO International licence renewals
- Manufacturing transfers especially to/from contract manufacturers,
- Clinical Trial Applications, especially Phase I/II (in not more than 2 countries),
- Parallel import applications
- Legalisation of key regulatory documents
Two Hats Regulatory Science GbR, can help you with these challenges by:
- Combining your GMP audits with our regulatory compliance & conformance audits (especially at contract manufacturers)
- Using Lean Sigma & process optimisation tools
- Conducting regulatory risk assessment , analysis & minimisation/communication
- Reviewing GMP related change control and improving processes between manufacturers and central regulatory teams/local affiliates/agents
- Training & mentoring of regulatory staff
- Providing interim management options
- Recommending qualified business partners
For those organisations in the non-profit sector and low-profit orientated companies, we can also help with:
- Reviewing scientific articles for grammar/clarity prior to sending to journals/media or helping with corrections
- Review processes to possibly make your work-flow(s) more efficient.