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CAPABILITIES
OVERVIEW
During the past several years,
SL Pharma Labs, Inc. has successfully completed a large number and
variety of projects for client companies nationwide and beyond, and has prepared documents
as part of the regulatory submissions (IND, NDA & ANDA) leading to their
acceptance/product approvals. SL Pharma's scientific staff offers over 150 years of
combined experience (gained in reputed pharmaceutical companies) in almost all aspects of
product development including formulation, analytical & microbiological development,
aseptic processing, clinical manufacture/development, manufacturing, regulatory
documentation & GMP compliance. SL Pharma is licensed and /or offers expertise in
handling cytotoxic as well as controlled drug substances.
SL Pharma Labs, Inc.
takes pride in undertaking complex and challenging projects. You may call this our
specialty! We offer extensive expertise (consultation as well as laboratory
services) in sterile drug product development/technology, clinical manufacturing,
parenteral, topical & intranasal dosage forms, antibiotic/antiseptic development and
in all aspects of analytical and microbiological development & testing.
SL Pharma Labs, Inc.
has had several FDA inspections (both GMP and PAI) with no 483!
Examples of SL
Pharma Labs' capabilities include:
Manufacture of lab-scale
& clinical batches (phase-I and phase-II) of parenteral, intranasal, topical and other
dosage forms
Analytical method
development, validation & release testing
Microbiological method
development, validation & release testing
Formulation
development/optimization of parenteral, intranasal and topical dosage forms
Cleaning validation
studies and methods development/validation
Dissolution method
development, validation & testing
Antimicrobial drug
product preclinical & clinical development & testing
Stability testing
(ICH/FDA)
Licensed to handle/ test
Controlled Drug Substances
Lyophilization cycle
development
Sterile filter
validation studies
Container/ Closure
integrity evaluation (physical & microbiological)
Manufacture of lab-scale
& small scale clinical, toxicology and stability batches of parenteral, intranasal,
topical and other dosage forms
Development and testing
of novel drug delivery systems, medical devices and nutraceuticals
Preparation of technical
documents for regulatory submissions
Provide assistance to
resolve complex technical/ regulatory issues with the FDA
Technology Transfers
Click
here to see our Equipment List
In addition to the above, SL
Pharma Labs, Inc. has developed strategic alliances/ partnerships with other
qualified well established companies to significantly expand the technical capabilities to
include: formulation development and clinical manufacture of solid dosage forms, and
scale-up plus commercial manufacture of other dosage forms.
SL Pharma Labs, Inc.
offers dependable, personalized and customized cost effective services. We save time
and money by enabling our clients to invest only in the specific studies or services they
need.
CONTACT INFORMATION
SL Pharma Labs, Inc.
can be reached as follows:
Address:
1300 First State Blvd., Suite C
Wilmington, Delaware 19804
Telephone:
(302) 636-0202 Eastern
FAX: (302) 636-0204
Email: Info@slpharmalabs.com
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