CMC

Analytical development services for oligonucleotides: For oligo-based drugs, our capabilities range from GLP bioanalysis to GLP/cGMP characterisation. We support product development, from quality control testing of amidite starting materials and early stage product characterization through to GMP batch rele...

With our global standard quality system, we are uniquely positioned to be your strategic manufacturing partner for reliable, cost effective long-term supplies of your intermediates and APIs from a few grams to metric tons. Our unique"end-to-end" platform ensures knowledge retention throughout your product lif...

BioDuro-Sundia holds more than 25 years of experience formulating poor solubility and  poor permeability drugs for the clinical studies. Our comprehensive suite of advanced formulation technologies and extensive scientific know-how supports >95% of marketed dosage forms. ...

Xedev is specialized in process development.

Do you have a drying, granulation of coating process which need optimization, Xedev can help you with the development, optimization and scale-up of your process.

We are using a stepwise approach to transfer your material to your own facilities...

Development of nasal drugs: Scientists from our nasal drug development team provide method development, validation, and testing services to help you optimise the performance of your aqueous, powder, and propellant-driven nasal drug products. Conducted in Good Manufacturing Compliant (GMP) laboratorie...

WuXi STA vertically integrated new modality platform, powered by WuXi Chemistry with both solid phase synthesis and liquid phase synthesis offers API to Formulation services including comprehensive analytical capability and know-how.

Oligonucleotide CRDMO platform from customized monomers, l...

WuXi STA drug product preformulation and formulation services and solutions can includes in vivo pk  with multiple animal species and fast turnaround.

WuXi STA's analytical support from laboratory process development to production through to regulatory data submission. Our dedicated analytical science and quality control teams provide our clients with a full spectrum of analytical method development, validation and testing services to support your needs fro...

BioDuro-Sundia’s Analytical Testing team offers high quality analytical services including method development and validation, qualification of reference standards, testing and release studies, stability studies, and CMC dossier preparation services. ...

BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts.
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70% of the new chemical entities (NCEs) synthesized are poorly soluble compounds, resulting in a low bioavailability. Bioavailability enhancement is the number one challenge in formulation development today. Xedev can help overcome complex bioavailability challenges and accelerate drug development process th...

WuXi STA's dedicated Global Regulatory Affairs CMC Team offers CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through forward-looking gap anal...

Our team of Regulatory affairs experts make our service offerings stronger. 
Following are our Regulatory offerings:

• Regulatory Operations, Affairs

• Regulatory Intelligence, Information Management COTS

• Regulatory Strategy & Business Consulting

• Health Authorit...

EAS can assist with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry, and biology are authorities in government laws and regulations. EAS can lead your company through the process of obtaining necessary background data, filing t...

BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development.

Our experts can advise you on pharmaceutical development strategy and provide oversight for the overall product development process to ensure key development milestones are successfully reach...