We provide regulatory-driven,
phase-appropriate, CMC laboratory and GMP analytical services. Our expertise
ensures sufficient information for your Investigational New Drug (IND),
Abbreviated New Drug Application (ANDA) and New Drug Application (NDA) filings.
This is achieved through analysis services, pre-formulation and solid state
characterization, method development and validation, stability studies,
pharmaceutical impurity analysis, extractables and leachables and GMP batch
release testing. Our scientists are adept at applying advanced technology in
GMP compliant analytical development programs.
Pre-formulation: Method Development and Validation, Stability Studies,
Dissolution Particle Size Distribution, Thermal Analysis,Viscosity, Melting
Point/Glass Transition Hygroscopicity, Powder Density /Flowability, Intrinsic
Dissolution, Excipient Compatibility, Solubility Dissociation Constant,
Specific Gravity, Disintegration
Formulation: Inhalation, Oral, Nasal, Parenteral, Topical, Transdermal
Facility & Equipment
We are located in the heart of the
Research Triangle Park life sciences cluster, with biotechnology and
pharmaceutical companies, academic research institutions and teaching
hospitals. The facility is designed for translational development activities
and is well-suited for the development of a wide range of compound types and
safety classifications, ranging from parenterals for biotherapeutics to oral
dosage forms for small and large molecule.
All our instruments are new or
refurbished to factory specs from major manufactures,chosen for their ability
to generate quality results.
1. PE-Sciex LC-MS, prep HPLC, FT-IR
2. Liophilization
3. Multi-Kilo scale reactors
4. Scale-up reactors
5. API5000 API4000 and API3000 series
with triple quard, and Q-trap systems
6. Agilent 1100,1200 series HPLC
systems
7. Agilent 5977AGC/MS, fitted with a
7697A headspace apparatus
8. UV/Vis spectrophotometers
9. FT/IR spectrometers
10. Karl Fisher, Optical Rotation
11. Elemental Analysis