EMINENT Services Corporation
Provider of investigational drug management, cGMP clinical manufacturing, analytical and information-technology services for pharmaceutical, biotechnology, academic and government clinical research. Services span formulation and bulk drug characterization, stability and analytical testing, controlled-temperature storage and biorepository, packaging/labeling and clinical distribution, plus regulatory and CMC support. The company also partners with CLIA/CAP-certified laboratory services to offer centralized diagnostics and high-throughput testing.
Industries
Nr. of Employees
small (1-50)
EMINENT Services Corporation
7495 New Technology Way, Frederick, MD 21703, USA
Products
Investigational Drug Management
Comprehensive management of investigational drugs, including formulation, development, manufacturing, testing, packaging, and distribution for clinical trials.
Regulatory Consulting
Guidance on regulatory affairs, including filing IND, NDA, and DMF with the FDA, and support for clinical product development and compliance.
Clinical Manufacturing
Manufacturing of pharmaceutical formulations, including placebos, with subcontracting arrangements for production and release of study products.
Packaging and Labeling
Design and development of primary and secondary packaging, and labeling solutions for clinical trials, ensuring regulatory compliance.
Bioavailability Studies
Conducting bioavailability and bioequivalence testing to assess drug absorption and distribution in the body.
Stability Studies
Testing the stability of pharmaceutical substances and products under various conditions to ensure consistent quality.
Investigational Drug Management
Comprehensive management of investigational drugs, including formulation, development, manufacturing, testing, packaging, and distribution for clinical trials.
Regulatory Consulting
Guidance on regulatory affairs, including filing IND, NDA, and DMF with the FDA, and support for clinical product development and compliance.
Clinical Manufacturing
Manufacturing of pharmaceutical formulations, including placebos, with subcontracting arrangements for production and release of study products.
Packaging and Labeling
Design and development of primary and secondary packaging, and labeling solutions for clinical trials, ensuring regulatory compliance.
Bioavailability Studies
Conducting bioavailability and bioequivalence testing to assess drug absorption and distribution in the body.
Stability Studies
Testing the stability of pharmaceutical substances and products under various conditions to ensure consistent quality.
Services
Regulatory guidance across the drug development lifecycle and preparation/review of CMC documentation for regulatory submissions.
Pre-formulation, formulation strategy and development to evaluate patentability and compress development timelines.
cGMP-compliant clinical manufacturing including OSD production, sterile fill/finish, automated packaging, labeling and serialization.
Analytical method development and validation, stability protocols, monograph testing and finished product release testing performed to compendial or validated procedures.
Secure investigational drug and biological specimen storage with redundant HVAC, continuous monitoring, backup power and electronic traceability.
Validated shipping solutions, customs-aware distribution, 24/7 shipment monitoring, and advance notifications for domestic and international shipments.
Regulatory guidance across the drug development lifecycle and preparation/review of CMC documentation for regulatory submissions.
Pre-formulation, formulation strategy and development to evaluate patentability and compress development timelines.
cGMP-compliant clinical manufacturing including OSD production, sterile fill/finish, automated packaging, labeling and serialization.
Analytical method development and validation, stability protocols, monograph testing and finished product release testing performed to compendial or validated procedures.
Secure investigational drug and biological specimen storage with redundant HVAC, continuous monitoring, backup power and electronic traceability.
Validated shipping solutions, customs-aware distribution, 24/7 shipment monitoring, and advance notifications for domestic and international shipments.
Expertise Areas
- Investigational drug management
- Clinical supply chain and distribution
- cGMP clinical manufacturing (sterile and non-sterile)
- Formulation development and bulk drug characterization
Key Technologies
- Laboratory Information Management System (LIMS)
- Integrated investigational drug management system (IDMS)
- Automated blister packaging and serialization
- ISO-class clean room sterile fill/finish
News & Updates
Describes company involvement in randomized, double-blind placebo-controlled clinical trials investigating semaglutide and tirzepatide across indications and notes availability of central lab services via an affiliated diagnostics laboratory.
EMINENT Services Corporation Expands Support for Food Allergy Research with Cost-Effective Solutions
Announces continued support for food allergy clinical trials, listing services such as sourcing, manufacturing, testing, randomization, labeling, distribution and central laboratory capabilities to reduce trial costs.
Describes facility expansion and upgrades including ISO-class clean rooms, ISO-class sterile fill/finish, automated packaging, and a new European facility focused on packaging and temperature-controlled storage.
Announces partnership and formation of an integrated life-sciences offering combining clinical trial support and CLIA/CAP-certified central laboratory services for companion diagnostics and sample management.
Details enhancements to packaging, labeling, serialization and cGMP environments alongside new budget-tailored solutions for CROs, academic and government investigators.
Describes company involvement in randomized, double-blind placebo-controlled clinical trials investigating semaglutide and tirzepatide across indications and notes availability of central lab services via an affiliated diagnostics laboratory.
EMINENT Services Corporation Expands Support for Food Allergy Research with Cost-Effective Solutions
Announces continued support for food allergy clinical trials, listing services such as sourcing, manufacturing, testing, randomization, labeling, distribution and central laboratory capabilities to reduce trial costs.
Describes facility expansion and upgrades including ISO-class clean rooms, ISO-class sterile fill/finish, automated packaging, and a new European facility focused on packaging and temperature-controlled storage.
Announces partnership and formation of an integrated life-sciences offering combining clinical trial support and CLIA/CAP-certified central laboratory services for companion diagnostics and sample management.
Details enhancements to packaging, labeling, serialization and cGMP environments alongside new budget-tailored solutions for CROs, academic and government investigators.