R&D Formulation

* Tablet,                                                          *Capsule,

     *film-coated tablet,                          *Sachet (Powder, Liquid)

     *enteric coated tablet,                    *Drop,

      *chewable tablet                              *Syrup,

 *Solution,                                                     *Cream,

*Oral mouthwash,                                 *Pomade,

*Lotion,                                                           *Ointment,

*Spray,                                                            *Gel.

We carry out R&D studies and scale-up production of generic drugs in various forms. We carry out technology transfer to contract manufacturing sites with GMP certification.

Analytical Method Development

• Potency evaluation
• Dissolution studies
• Impurity 
• Moisture
• Heavy metal
• Residual solvents
• Physical and chemical tests
• Cleaning method
• DMF applications-updates
• Other customer-focused tests
• Drug stability tests
• In vitro-in vivo correlation (f2 and f1 evaluation)

All analytical methods and their validations are developed and documented by our R&D team

Quality Control and Microbiological Tests

Physical, chemical and microbiological analyzes of all starting materials, finished products and stability samples are carried out in our laboratory with state-of-the-art analytical equipment using EP, BP, USP, JP/JPE and in-house methods.

Licensing Services and Follow-up

• Preparation of drug files and licensing (Traditional Herbal Medicinal products, Prescription/non-prescription drugs, CTD application and frollow-up), 
• SmPC/Leaflet applications,
• Price applications,
• Sales permit applications,
• Preparation of license transfer files,
• Preparation of license renewal files,
• Lost license applications,
• Preparation of export-to-import files,
• CPP, FSC applications,
• Determination of the scope of variation (Type IA, Type IB, Type II) in line with the current variation guide, preparation and follow-up of the variation file.