GMP Production Validation

RiboBio provides API manufacturing service for clinical research by following the cGMP requirements of Chinese GMP (2010), ICH Q7, 21 CFR Part 210 & 211 and Part 11, EudraLex – Volume 4, etc. Based on the production process, design the batch manufacturing records in Chinese and English to meet the submission requirements for global clients; in accordance with related regulations on data integrity, keep the complete digital data and paper records for production submission and verification to fulfill the quality requirements for treatment or diagnostic oligonucleotide-based API manufacturing.

Case Studies

One foreign client needs to apply for clinical research in China and overseas; one domestic client hopes to apply for clinical research in US only, which they both require Chinese and English version for all product records and files. RiboBio can provide the files and batch manufacturing records in Chinese and English to meet submission requirements.