CMC

Laboratory services according to GMP and CMC: We provide regulatory-driven, phase-appropriate laboratory services, supporting CMC programs from preformulation to formulation to product release. Among our capabilities are centres of excellence for method development and validation, analysis, stability s...

1.Custom Synthesis 2.R&D of Synthetic Processes and Custom Manufacturing 3.Contract Manufacturing Service 4.CMC Service for New Drugs

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 form...

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 r...

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) laborato...

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. qq...

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 Autho...

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 ...

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,...

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, filin...

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 re...