With available state of art equipment in Analytical, Clinical and manufacturing facility Auriga is offering complete formulation dossier to it clients. We provide the following window of services to Pharma Companies in formulation development.
- API Sourcing
- Selection of Inactive Ingredients
- Prototype formula development
- Final Formula Selection
- Brief Manufacturing Procedure
- Stability Studies of Prototype Formulation
- Prototype finalization
- Finished Product Specifications – Justification of Specifications
- Control of Excipients
- Justification of overages
- Process optimization studies on Scale-up Batches
- Manufacturing process optimization
- Stability Studies on Scale-up Batches
- Bioequivalence Study on Scale-up Batches
- Physical/visual comparison of final formulation vs comparator
- Comparative analytical results of final formulation vs comparator
- Comparative In-Vitro Dissolution Profile of final formulation vs comparator
- Comparative Multimedia Dissolution Profile of final formulation vs comparator
- Assisting fillings of Drug Master Files in various countries.
- Assisting registering products in various countries.
- Assisting to face Regulatory Audits
- Assisting to file Dosage forms in various countries.
Bio waiver Application:
Auriga has alredy supporting to prepare biowaiver dossier for products on basis of dissolution testing which is a surrogate for bioequivalence testing for BCS class I and class III. We have alredy idetified list of molecules for biowaiver application.
We also offer Expert Reports for pharmaceuticals products Clinical, Pharmacological and Toxico-Pharmacological as per regulatory requirements