TECHNICAL DOCUMENTATION : Our Regulatory Affairs Division comprises a group of Pharmacists, Veterinarians and Chemists who provide all technical documentation with regard to the active ingredients and also support for the finished formulations. They can provide the following documents :
Drug Master File is available – Open Part of the DMF as per the EEC Format against a Secrecy Agreement
directly from the customer. All the documents can
be provided to the customer on request.
Method of Analysis – Besides/in addition to the official pharmacopoeia.

  • Material Safety Data Sheet (MSDS)
  • BSE/TSE declaration.
  • Reference Working Standard and Impurity Standards
  • Impurity Profile complying to ICH Standards
  • Registration Dossiers for the Finished Formulations
  • Toxicity Data
  • Stability studies
  • Bio-equivalence and Bio-Availability Studies are available.

Due to the above technical support guaranteed by the Company, the customers opt to purchase several products from the company as the availability of such documents fulfill customers technical and regulatory requirements and hence we are able to develop a long term business relationship with several customers.

 

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