GMP Analytical Services at Daicel
Daicel Pharma Services provides innovative analytical solutions (method development, validation, transfer, and characterization) to support timely and safe drug development with improved cost efficiency. We support the domestic and global pharmaceutical industry from the development stage to commercialized products.
We have a dedicated and experienced team of analytical scientists and a quality assurance team capable of providing documentation support – CMC, IND-CTA, EMA, DMF, and ANDA – in line with global regulatory requirements for both drug substance and drug product (US FDA, EU and Brazilian) filings.
- First ISO: 9001-2008 accreditation: SEP 2011
- First submission of DMF: SEP 2013
- First FDA audit: FEB 2016
- First ISO: 9001-2015 accreditation: OCT 2017
- Number of projects supporting regulatory submissions (ANDA/DMF): 100 projects per year
A wholly-owned and operated subsidiary of Daicel Corporation, Japan, our facility offers a wide range of Analytical Research and Development services.
To be your preferred global Analytical Services partner.