Does anyone have experience in submitting TSE dossiers to EDQM? Our certification is expiring this year so I am updating our dossier, and we're having some trouble really understanding what's expected. Their guidances are pretty fuzzy about how much detail/length they expect. 
The people who wrote our previous dossier included a lot of information and many appendices (e.g., all the supporting laws and regulations in the countries from which our tissues are sourced). We're thinking that this is overkill, but would love to hear from others who have successfully submitted these dossiers.
Thanks in advance for any information you can provide!
Jen
The people who wrote our previous dossier included a lot of information and many appendices (e.g., all the supporting laws and regulations in the countries from which our tissues are sourced). We're thinking that this is overkill, but would love to hear from others who have successfully submitted these dossiers.
Thanks in advance for any information you can provide!
Jen