The Final objective
is to ensure that good quality products are delivered to the end
user as per customers needs. This is possible through a very firm
commitment towards quality within every area of the organization.
Every possible effort is done to ensure quality is maintained and
there is a coninious supply of quality products.
We have a process
for qualifications of our products and supporting manufactueres.
This includes :
( as and when required )
The manufacturing site follows and meets all the GMP requirements
as required by the law of the importing country.
Product finally delivered adhers to the standards and specifications
inclused assurance of systems in place such as the manufacturing
license, site master files, quality manufales, drug master files
as the ase maybe. In case of site audits are required we outsource
them to the experts and are audited by qualified auditors.
site variations, validation, deficiency letters are a part of the
product registration challenges faced today. The overall activities
of the regulatory affairs divison is to obtain Marketing Authorization's
for generic products in the developing world. A team is dedicated
to the work of co-ordination, collectionof documents, compiling,
preparing dossiers as requried yb each individual national registration
authority and to maintain these Marketing Authorizations thereafter
. Whether these are variation files for site transfer or API variation,
all data and relevant documentation in the right form must be delivered
to the customer and the Ministry of health covering lablels, leaflets,
int eh language required.
and compiling all dossiers for varisou registraion needs
all deficiency letters.
Updataion of dossiers as and when needed.
Revalidation documentations for site transfers, additions-
The challenges are met by our teams
along with the support of the manufacturer's and thier QA and QC
Partnership We are committed to build
a long term relationship with all our business partners for mutual
interest and benefits.