EMINENT Services Corporation

7495 New Technology Way
Frederick
Maryland
21703-9401
United States

Tel: 240-629-1972 or 877-EMISERV
Fax: 240-629-3298

Email: service@emiserv.com

About EMINENT Services Corporation

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

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