All stage
:
SinoT provide high standard and regulatory complaint quality standards, analytical services and
dossier preparation.
Preclinical
Enabling measures to meet in vivo exposure requirements for pharmacodynamics and
toxicology studies.
IND
Fit-for-purpose design/strategies that are tailored to meet specific compound
requirement and prompt execution with speed.
Phase
Ⅰ
Phase
Ⅱ
Respond in a timely manner to meet clinical trial/supply requirements and deliver
clinical samples with high quality and without delay.
Phase
Ⅲ
Our proficient technical teams will develop robust formulation and processes, accurately
identify CQA and CPP, implement DOE by QbD principles and formulate control
strategies that is feasible to meet the requirements of commercial manufacturing and
new drug NDA application.
NDA
Commercial
production
We have extensive experiences in commercial production, and have a track record of
timely and reliably supplying commercial products.
Product Lifecycle
Management
We have good experiences and tract record in providing solubility-enhanced
formulation
,
sustained release/controlled release, appearance improvement, new
dosage form/strength selection to extend a product lifecycle.