Medicilon Cmc Services - Chinaprice: 1.00 Dollar US$
1.The development and validation of analytical method
Develop and validate the analytical method according to the features of dosage form and the APIs.
1)Method validation for enantiomers
2)Method validation for impurities
3)Method validation for content uniformity
4)Method validation for assay
5)Method validation for microbiology
6)Dissolution method validation
2.Quality research of the products
Quality research base on the character of dosage form and compound and relevant guideline.
7)Dissolution curve (12 units/lot)
8)Moisture or loss on drying.
3.Determine the specification for final products
2)Protocol of quality standard
Accelerated and long-term stability test based on ICH guidance and CFDA guidance
Forced Degradation Testing
Accelerated Stability Test
Long-term Stability Test
The development and validation of analytical method
Consistency evaluation of formulation by quality specification
Make solution base on evaluation result
IVIVC of the Product
We provide the service of IVIVC of the product.
Registration and Submission
Data processing for the registration dossier
Compiling and translation of the registration dossier.
Registration & Submission
Our CMC experts with decades of experience are familiar with various ICH and CFDA regulations and guidelines. We have helped many clients to complete their pre-formulation and formulation studies and provided reliable data for the regulatory submissions. We have already successfully assisted many clients to complete the 1.1 class, 3.1 class and 6 class new drugs for CFDA application.
- Posted By: Shanghai Medicilon Inc.
- Phone: +862158591500
- Address: 585 Chuanda Road,Pudong,Shanghai201299,China, Shanghai, Pudong New Area, China
- Website: http://www.medicilon.com
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.
Formulation Development ServicesMedical - Services - Other - Shanghai Medicilon Inc. - China - September 1, 2016 - 1.00 Dollar US$
Formulation Development Services NDA Formulation Strategy Suspensions (microsuspensions & nanosuspensions) API filling into bottles (powder in bottles) API encapsulation / vial filling using Xcelodose 120S & 600S Dry blending and encapsulatio...
Analytical Development ServicesMedical - Services - Other - Shanghai Medicilon Inc. - China - September 1, 2016 - 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 r...
Pre Formulation DevelopmentMedical - Services - Other - Shanghai Medicilon Inc. - China - September 1, 2016 - 1.00 Dollar US$
Preclinical Candidate Characterization Solubility: pH solubility profile Solubility in organic solvents Solubility in Fasted State Simulated Intestinal Fluid (FaSSIF), Fed State Simulated Intestinal Fluid (FeSSIF) and Simulated Gastric Fluid (SGF) St...
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