Contract Formulation & Process Development
Contract Formulation & Process Development

Fluid Bed Technology

Drug Delivery Systems




offers comprehensive pharmaceutical formulation and technology development activities for our global pharma customers especially for the regulated markets. Our research work will be in total compliance to all global regulatory standards and requirements and is very cost effective. We work in accordance with pre approved developmental protocols and MOUs with payments based on milestones of performance. Thus you are actually able to monitor your progress and value for your money is assured.

Our main thrust area is to offer our services for pharma companies who want to outsource their generic drug development for ANDA filings with the FDA and get their marketing authorizations from the FDA.

Generic market is a very huge market in the western hemisphere, and with the huge list of drugs whose patent is close to expiry, there is virtually a race within the generic companies for getting marketing authorizations for off patent drugs. A sure and safe way of ensuring that the company is not losing out on opportunities is to simply ‘outsource’ the overflow research jobs to .

Our activity is split in to mainly the following components:

  • Full fledged developmental activity as per the global regulatory requirements
  • Dossier will be provided on pre-formulation work through scale up work including limited BA / BE testing on up to 24 volunteers
  • Complete stability studies on accelerated and ICH guidelines
  • Dossier will be provided on CTD formats
  • Our facility will be subject to total technical audits by customers as & when desired.
  • Each new product development will be carried out over a period of 9-12 months
  • All projects will be carried out conformable to FDA requirements
  • Assignments will be initiated upon a CA / MOU and an advance. Subsequent payments on pre-agreed Milestones
  • Non Disclosure agreements will be signed before start up.


 

Powered by Gayatri Microsystems