Isogen
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Contact:
Stephen Tingley
Director, Business Development
Phone #: 302 369 7040
Phone #: 856 853 4608
Fax #: 856 853 4609
Email: info@isogenllc.com
Website: www.isogenllc.com |
Address:
1090 Elkton Road, Bldg 115
Newark, Delaware 09117
USA
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Company Description:
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Isogen is an integrated provider of contract GMP Sterile Clinical filling, process development and analytical testing services. Our advanced sterile processing facility provides complete segregation and containment of the manufacturing process ensuring a secure multi-product facility, capable of handling a wide range of therapeutic products including potent and BSL2 category products. |
Additional Information:
Isogen deals in the following categories:
| Analytical Lab Services |
Analytical Methods Development |
| Analytical Validation Studies |
Aseptic Processing |
| Assay Development |
Auditing |
| Biological Testing |
Chromatographic Analysis, LC/GC |
| Commissioning |
Consulting |
| Consulting, Audits & Inspections |
Consulting, Process Analytical Technology (PAT) |
| Consulting, Process Excellence |
Consulting, Regulatory |
| Consulting, Six Sigma |
Contract Development and Manufacturing Organization (CDMO) |
| Contract Manufacturing |
Disposable Device Development & Manufacturing |
| Dosage Form Development |
Endotoxin Testing & Removal |
| Engineering and Design Services |
Expert Testimony |
| Extractables / Leachables Testing |
Facility Construction |
| Facility Design |
Facility Planning |
| Filling, Ampule |
Filling, Syringe |
| Filling, Vial |
Forced Degradation Studies |
| Formulation Development |
Formulation Services |
| GMP Auditing |
HPLC |
| Lot Release Testing |
Lyophilization |
| Manufacturing, Aseptic Fill/Finish |
Manufacturing, Clinical Trials Supply |
| Manufacturing, Consultants |
Manufacturing, Custom |
| Manufacturing, Cytoxic & High Potency Compounds |
Manufacturing, Dose Form, Sterile |
| Manufacturing, Ethical |
Manufacturing, Generics |
| Manufacturing, High Containment Operations |
Manufacturing, Injectables |
| Manufacturing, Parenterals, Small Volume |
Manufacturing, Syringes Pre-filled |
| Materials Analysis |
Methods Development |
| Methods Validation |
Microbiological Testing |
| Parenterals Development |
Parenterals, Ampule Filling |
| Parenterals, Vial Filling |
Photostability |
| Physical Testing |
Pilot-Scale Filling |
| Process Development/Scale-Up Services |
Process Validation Studies |
| QA/QC |
Raw Materials Analysis |
| Regulatory Affairs Consultants |
Scale-Up |
| Stability Studies |
Stability, ICH |
| Statistical Analysis |
Sterile Filling |
| Sterility Testing |
Sterilization |
| Syringe Filling |
Technology Transfer |
| Training |
Training: cGMP/HPB/FDA Compliance |
| Training: Process Validation |
UV-VIS Spectrophotometer Analysis |
| Validation, Equipment Cleaning |
Validation, Filtration |
| Validation, Manufacturing |
Validation, Services |
| Water Testing: Chemical |
Water Testing: Microbiology |
| Wet Chemical Analysis |
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