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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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