Our staff works closely with each customer to provide documentation
that meets cGMP requirements and ensures consistent product quality. This
close partnership with our customers has provided the working basis for the
development of new products and the commercial manufacturing of FDA-approved
products.
As
part of our commitment to quality and to our customers, we provide a wide
range of services specializing in:
- Research &
Development assistance for your new product
- Continuous
Improvement assistance to your existing product
- Writing and
performing validations for the lyophilization of your product
- Assistance
with commercializing your product
- Writing and
maintaining manufacturing procedures for cGMP compliance
- Formulation of
your bulk product prior to lyophilization
- Full laboratory
service including eutectic analysis, thermal profile, and moisture determination
- Additional
QC Testing available upon request
- Creating labels
for your product
- Labeling and
packaging of your product upon completion of processing
Our
customers can be assured that all our equipment is validated and kept
under
a strict preventive maintenance schedule, and that our facility and documentation
are all kept in accordance with cGMP regulations and ISO 9000 guidelines.
We
at LSNE, are committed to quality. Every operation is carried out with
the utmost care for quality results. As a FDA-regulated company, we are held
to this standard every day.
