You will benefit from substantial experience and the professional background of our consultants, trainers and auditors when re-structuring SOP’s, training staff on the latest regulations, or auditing study sites, internal departments or suppliers.
- Expertise in European clinical study regulations for pharmaceuticals, biologics, vaccines and medical
device product development
- Performance of the following types of audit: Quality support (co-monitoring); Clinical study on-site; Clinical study in-house; System and qualification audit
- Review study documentation
- SOP writing, review and training
- Regulatory and ethics committee submissions with input from experts on local requirements
- Assurance on quality and regulatory compliance of your clinical development programme