The guideline on setting health based exposure limits for use in risk identification for the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), which is supported by the Questions and Answers (EMA/CHMP/CVMP/SWP/246844/2018) and the Overview of Comments (EMA/CHMP/SWP/364535/2015) documents was implemented:
1st December 2015
For medicinal products introduced for the first time into shared manufacturing facilities.
1st June 2016
For manufacturers of products for human use already produced in shared manufacturing facilities (unless existing arrangements scientifically justified) including those who manufacture human and veterinary medicines using shared manufacturing facilities.
1st June 2017
For manufacturers solely producing products for veterinary use (unless existing arrangements scientifically justified).
To meet guidelines on shared facilities requirements within the deadlines imposed, we offer customized PDE monographs for all concerned products.
We have already developed a database containing more than 1,500 PDE monographs.
You can check Tox by Design methodology for PDE Monograph, which are duly validated and signed by an European Registered Toxicologist expert.
당사는 이제 주식회사 티비디(TVD Co., Ltd.) 국내 계열사를 통해 한국에서 현지 세금계산서를 발행할 수 있게 되었습니다. 이를 통해 현지 규정을 준수하며 더욱 원활한 거래 진행이 가능합니다
자세한 사항은 견적 요청(Quotation Request) 버튼을 클릭하여 영업팀으로 문의해 주시기 바랍니다
Feel free to contact us using the Quotation Request below to receive a quotation for PDE Monograph for your Active Pharmaceutical Ingredient, New Chemical or Biological Entity or any Chemicals substances deployed in your GMP manufacturing lines.