(KO to EN) Integrated analysis of safety data in clinical studies on patients with chronic renal failure

(KO to EN) Package leaflet of a drug for the treatment of hypercalcemia

(KO to EN) Risk management plan (RMP) of a therapeutic recombinant DNA-derived product

(KO to EN) Press release; Development of next-generation stem cell therapy products

(KO to EN) Sample analysis report; determination of plasma concentration in rabbit plasma using a LC-MS/MS method

(KO to EN) SOP for in vitro biological activity assay

(KO to EN) Protocol for and report on qualification of ligand binding assay using surface plasmon resonance (SPR)

(KO to EN) CSR Synopsis; non-inferiority clinical study

(KO to EN) Protocol Synopsis; a phase 3 clinical study in patients with pruritus due to skin disease

(KO to EN) Statistical analysis plan (SAP) for data obtained from a phase 3 clinical study

(KO to EN) CSR, protocol, and statistical analysis report; a long-term follow-up observational study of a gene therapy product in patients with degenerative arthritis

(KO to EN) Manufacturing processes of an investigational drug product, description and composition of drug product

(KO to EN) CTD Module 3.2.P.4 Control of excipients, 3.2.P.5 Control of drug product, 3.4.P.5 Control of placebo

(KO to EN) Patient information leaflet, Important drug warning

(KO to EN) SOPs for confidential agreement, protocol agreement, list of source documents, receipt of IP, IP inventory log, return of IP, IP storage temperature excursion report, destruction record, and CRA quality check report

(KO to EN) Vendor confidentiality agreement

(KO to EN) SOP for information security management

(KO to EN) SOP for project audit, project audit report, system audit plan, system audit notification letter, system audit thank you letter, and system audit report

(KO to EN) Work instructions for SAE report completion, SOP writing, site monitoring visit report completion, and authorization form completion

(KO to EN) CSR; a bioequivalence study of an anti-alopecia drug in healthy adult male subjects

(KO to EN) GMP inspection report

2019

KO: Korean, JP: Japanese, EN: English

(EN to KO) Briefing document for orphan-drug designation

(EN to KO) Specifications and analytical procedures

(EN to KO) Safety and efficacy of **** in Korean patients with long-chain fatty acid oxidation disorders

(EN to KO) Investigator’s brochure, acknowledgement of receipt

(EN to KO) Drug approval systems in German and France

(EN to KO) CTD 2.3.P.1 Description and composition of drug product

(KO to EN) Summary of pharmacoeconomic evaluation

(KO to EN) Quality agreement for contract manufacturing

(KO to EN) Patent infringement analysis report

(KO to EN) Batch production records, batch packaging records, cleaning methods

(KO to EN) Investigator’s brochure

(KO to EN) Clinical study report (CSR); a bioequivalence study

(KO to EN) TSE/BSE safety of UDCA

(KO to EN) Case report form (CRF), post-marketing surveillance (PMS) protocol

(KO to EN) SOP for system audit and CAPA management

(KO to EN) Statistical analysis report of pharmacokinetic data in bioequivalence studies

(KO to EN) Clinical study protocol; a phase 1 clinical study in health adult volunteers

(KO to EN) Clinical study report (CSR); a phase 1 clinical study in patients with neovascular age-related macular degeneration

(KO to EN) Clinical study report (CSR); a phase 1 clinical study in pediatric patients with solid tumor

(KO to EN) CSR; a phase 1 clinical study in healthy Korean and Caucasian Subjects

(KO to EN) Investigator’s brochure of a novel antidiabetic drug

(KO to EN) CSR Synopsis; a phase 2 clinical study in patients with erosive gastroesophageal reflux disease (GERD)

(KO to EN) User requirement specification, risk assessment report, installation qualification report, operational qualification report, performance qualification report

2020~현재

KO: Korean, JP: Japanese, EN: English

(JP to KO) Clinical laboratory findings of a new anti-cholinergic agent

(EN to KO) Specifications and analytical procedures

(EN to KO) Materials safety data sheet (MSDS)

(EN to KO) Clinical hold complete response

(KO to EN) Report on the development of antibody-based technology using cIEF

(KO to EN) Testing for inter-species cross activity of novel antibody against ErbB3

(KO to EN) ELISA assay for qualification of antibodies

(KO to EN) Western blot analysis of ErbB family and Akt1 in tissues

(KO to EN) Binding ability of novel antibody to ErbB3 on the surface of cancer cells

(KO to EN) Study to evaluate the cytotoxicity and inhibitory effect of novel antibodies on choroidal neovascularization (CNV)

(KO to EN) DNA cloning and hybridoma sequencing

(KO to EN) CTD Module 3. Quality of an injectable prepration