Office Address:
Shreejaya Laboratories Pvt. Ltd., Plot No. 11 Sy.No.342 , ALEAP Industrial Area, Near Pragathi Nagar, Hyderabad-500 090.
Quality Assurance
Quality Assurance
The pharmaceutical industry is characterized by its dynamic nature, with continual shifts in regulatory frameworks and healthcare sectors. This landscape demands expert regulatory guidance in order to Streamlining your program from early development to commercial.
Our Quality System is based on the cGMPs and adheres to the relevant quality guidelines as ICH & 21CFR and allows us to meet high compliance standards while implementing continuous improvement processes.
Inspections & Audits
Our facilities are regularly inspected by Health Authorities (FDA) and customers. We have more than 15 years experience with a very good inspections results.
FDA (US) Inspections: 2 FDA Inspections in 2016 to 2022.
Analytical Services.
Our analytical departments support the whole product lifecycle :
- Development of new analytical methods
- Development of new analytical methods
- Development of new analytical methods
- Development of new analytical methods
- Support the cleaning validation activities
- Stability studies to define retest/expiry period of the intermediates and APIs
- Characterization of standards and impurities
Regulatory Affairs.
Our Regulatory Affairs team has an important role in any project during all the lifecycle, in order to prepare and deliver the necessary registration documentation for the intermediates and APIs for submission to the regulatory authorities (US Food and Drug Administration (FDA), European Medicines Agency (EMA), European Directorate for the Quality of Medicines (EDQM), Japan PMDA, China FDA (CFDA)…)
We prepare and deliver the necessary registered documentation for active pharmaceuticals ingredients (APIs) and intermediates for submission according to the guidelines
- Drug Master Files for the EU, USA, Japan, China as well as other worldwide markets
- Complete CMC documentation (Module 3.2.S) for approval applications
- EP-Certificates of Suitability (CEP)
- Notifications of change
- Assessment reports according to ICH Guidelines (genotoxic and mutagenic assessment, elemental impurities, residual solvents…)
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