Analytical Development Services - China

Analytical/Stability/CMC Package for IND/CTA, NDA/MAA & ANDA

End-to-end services with high quality and fast turnaround time providing cost effective solutions

One stop to shop for all the needs in analytical & stability, quality control and regulatory CMC documentation

Package qualified for both China and global submission (“China for China” and “China for global”)

Method Development and Validation

A wide range of chromatography techniques (HPLC, UPLC, GC, and IC) and detection technologies (UV, MS, MS/MS, CAD, ELSD, RI, FID, ECD, ICP, Florescence, etc) to meet the requirements of different types of compounds

Stability-indicating assay and/or related substances methods for drug substance and drug products (tablets, capsules/liquid filled capsules, solution/suspension, powder, beads/coated beads, injectables, topicals, solid dispersion, etc)

Other specific methods such as dissolution (IR, ER, MR), residual solvents, potential genotoxic impurity, enatiomeric separation, cleaning validation, counter-ion, microbiological test, etc

Provide method development experimental design, progress report, method validation protocol and report, method monograph

Phase appropriate approaches – qualified for IND/CTA or NDA/MAA application

Analytical Testing and Release

Analytical support for formulation development and cleaning validation

Reference standard characterization with CoA or full characterization report

Confirmation of structure or absolute configuration determination

Structure elucidation for impurity/degradation product by LC/MS/MS and a variety of NMR spectroscopy

Degradation pathway ascertainment with report for regulatory submission

Leachable / Extractable testing

Stability Study

Global registration stability; experimental/probe stability; post-approval commercial stability

Comprehensive services with stability protocol design, program management, storage and testing, data trending/shelf life assessment up to dossier preparation for NDA/MAA application

Storage conditions: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH and light or customized conditions including 2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20, 50/40 (new)

Qualified stability rooms/chambers (IQ/OQ/PQ and mapping); multiple types of power supply; real time temperature and humidity monitor (dual systems); autodial alert system

Regulatory CMC Documentation

Dedicated regulatory writing group with strong documentation experience and proven track record for global and China submission

CTD-format with version control or customized to meet local requirements

Further integration with IND-enabled toxicology and clinical and regulatory services

Company Contact:

• Posted By: Shanghai Medicilon Inc.

• Phone: +862158591500

• Address: 585 Chuanda Road,Pudong,Shanghai20129 9,China, Shanghai , Pudong New Area, China

• Email:

• Website: https://www.medicilon.com

• Business Description: Medicilon offers fully integrated pharmaceutical services for the global scientific community.
  
  We focus on providing an exceptional client-centered experience and advancing the drug discovery process.
  
  Since the founding of our company in 2004, our integrated services across biology, chemistry and preclinical services are uniquely designed to help clients developing their research and discovery programs from the initial idea stage to the IND filing phase.