EMINENT Services Corporation
7495 New Technology Way
Frederick
Maryland
21703-9401
U.S.A.
Phone:
240-629-1972 or 877-EMISERV
Fax:
240-629-3298
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EMINENT Services Corporation was founded in 1997 and is a privately owned company and is the pre-EMINENT provider of Pharmaceutical and Information Technology Services for pharmaceutical and biotech Industry and Research Organizations including Federal Government. EMINENT offers specialized regulatory guidance throughout the Drug Development Cycle, from bulk drug characterization to product launch and reimbursement support. Our personnel have extensive experience with investigational drug management.
All operations of EMINENT are performed in strict compliance with current Good Manufacturing Practice (cGMP) regulations and a comprehensive body of Standard Operating Procedures. EMINENT has been inspected by FDA and other regulatory agencies and possesses the required permits and licenses to conduct business in performing our services offered. All such inspection documents are available on our website for viewing at www.emiserv.com. EMINENT has the following capabilities at its 57,000 square foot facility located in Frederick, MD.
Regulatory Consulting Services
Pharmaceutical Research Laboratory
Clinical Supplies Manufacturing
Investigational Drug Repository
Label Design & Printing
Packaging and Labeling Facility
Direct to Patient Pharmacy
Biological Repository
Services We Offer:
Regulatory Consulting Services
Total Quality Implementation
QA/QC / cGMP / ISO9001 Compliance Auditing
Clinical Protocol Review
Equipment Qualification and Process Validation
Validation and Mapping of Drug Storage Areas
Shipping Configuration Validation
IND / NDA / ANDA / DMF Preparation
Commercial Product Launch
Review of Chemistry, Manufacturing and Controls (CMC)
Pharmaceutical Research Laboratory
Bulk Drug Characterization
Pre-formulation Studies/Formulation Development
Clinical Product Manufacturing
Analytical Methods Development & Validation
Stability Evaluation & Compendial Testing
USP/NF Monograph Analysis
Stability Protocol Preparation & Monitoring Services
Clinical Supplies Manufacturing
Manufacturing of Controlled Drug Substances
Manufacturing of Matching Placebo Formulations
Development of solid, oral, parenteral, dermal, and nasal formulations
Over encapsulation
Investigational Drug Repository
Storage and Global Distribution of Study Products including controlled substances
DEA Approved Cage/Vault for CII - CV
Bulk Drug Dispensing/Weighing
Hazardous Material Storage
Study Product Reconciliation
Clinical Site Inventory Monitoring
Return Drug Handling/Destruction
Drug Recall notifications to clinical sites
Label Design & Printing
Designing of custom labels
Printing multi-panel labels for blinded studies
Printing two or three dimensional barcodes, temperature sensitive labels, booklets, etc.
Printing labels with in-house or client provided randomization
Multilingual labels (including Arabic, Chinese, Japanese, Russian, Spanish, etc.)
Patient Quick Reference cards
Packaging and Labeling Facility
Design & Implement Novel Strategies for Investigational Drug Distribution
Clinical Subject Randomization
Specialty Packaging Configuration Design
Primary Product Packaging
Primary or Secondary Patient Specific Kit Packaging
Clinical Product Labeling (patient specific and open label)
Child resistant Blister Card Packaging
Bottling and Induction Sealing
Direct-To-Patient Pharmacy
Clinical Emergency Hotline and Emergency Drug Distribution
Compassionate Use/Patient Assistance Programs
Biological Repository
Storage and Distribution
Cataloging / Archiving
Aliquoting
Tracking of pre-clinical and clinical samples
Biological Laboratory
Information Technology Management Services
Project Requirement Assessment
Systems Design and Implementation
Validation and Acceptance Testing
Preparation for Disaster Recovery
Data Acquisition Systems Design
Application Development
Web Development
Clinical Site Drug Allocation
Value Added Services
Online Project Status and Inventory Reporting
Investigational Drug Requests via secured website
In-house developed sophisticated software system to handle on-site drug management
Automated monthly email Reports
Shipment notification and acknowledgment follow-up
24/7 emergency hotline service
Weekend Shipments
Email: info@emiserv.com
Website : http://www.emiserv.com
Email:
service@emiserv.com
Ownership:
Private
Web Site:
EMINENT Services Corporation
Employees:
Symbol:
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