80 visiting now: 39 France France flag 23 China China flag 14 USA USA flag 2 Sweden Sweden flag 1 Singapore Singapore flag 1 UK UK flag

Analytical Development Services - China

price: 1.00 Dollar US$

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:

  • Phone: +862158591500

  • Address: 585 Chuanda Road,Pudong,Shanghai201299,China, Shanghai, Pudong New Area, China

  • Email: Email

Published date: September 1, 2016 -

  • 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.

Related listings

  • Pharmacology Cancer Xenograft Models
    Pharmacology Cancer Xenograft Models
    Medical - Services - Other - Shanghai Medicilon Inc. - China - September 1, 2016 - 1.00 Dollar US$

    Medicilon has over 100 well-characterized Tumor Cell Line Xenograft models. Our experienced staffs operate with strong theoretical basis. We offer the services which are flexible for custom development of various types of models to meet the requireme...

  • Preclinical Research Service
    Preclinical Research Service
    Medical - Services - Other - Shanghai Medicilon Inc. - China - September 1, 2016 - 1.00 Dollar US$

    Preclinical Research Service Quick start experiments and flexible experimental design help you to speed up your decisions and lower your research cost. Drug Metabolism and Pharmacokinetics Pharmacology Services (Animal Models) Drug Safety Evaluation ...

  • Pharmacokinetic In Vivo Assays
    Pharmacokinetic In Vivo Assays
    Medical - Services - Other - Shanghai Medicilon Inc. - China - September 1, 2016 - 1.00 Dollar US$

    Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and ant...

Safe Trade Tips

  • Ask for business references and check them
  • Use a payment method that offers better protection for all such as Letters of credit and verified professional escrow services. Avoid payments in advance such as money transfers
  • Verify their business via their local Chamber of Commerce
  • Search the internet using their website address, their business name, their phone and fax numbers, and their email addresses to see if you can find any feedback about them.
  • Get to know more about scams to avoid: Internet Crime Complaint Center - International Financial Scams
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"