|
Covance Health Economics and Outcomes Services - covance.com
Specializing in reimbursement planning, development, and implementation of economic support strategies and health outcomes research for the pharmaceutical, biotechnology, medical device, diagnostics, and health services industries
clinical phase ii phase iii biostatistics biometrics data cardiovascular cns oncology pediatric womens health infectious disease regulatory canda nda clinical trials pharmaceutical crf regulatory
|
| |
|
DZS Software Solutions - clinplus.com
DZS Software Solutions, Inc. is the developer of the ClinPlus software for clinical data management, remote data entry, statistical analysis, reporting and coding (including MedDRA)
clinplus clinical data management meddra ecrf clinical trials software biostatistics cro nda clinaccess clintrials oracle clinical sas sas-based
|
| |
|
Ehrreich Consulting, Inc. - regsolutions.com
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission
fda fda consultants fda approval fda drugs regulatory affairs stewart ehrreich drugs drug policy drug design fda development regulatory solutions regulatory consultants fda regulations nda ind ide pma pla drug regulations regulatory issues regulatory problems
|
| |
|
Lewis CMC Consulting - lewiscmc.com
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services
regulatory affairs fda compliance fda regulations fda filings drug master files post-approval submissions regulatory consulting services cmc strategy ctx validations pharmaceutical liaison dossier templates dossier preparation cgmp inspection cgmp nda anda chemistry manufacture controls emea submissions
|
| |
|
Reg123.com - reg123.com
Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process
regulatory affairs professionals information new medicinal product development clinical drug trials pharmaceutical drugs company and research clinical research marketing authorisation mda drug development process marketing approval health care industry fda food and drug administration nda ctd cder cpmp cber epar ind uk usa
|
| |
|
RegSource, Inc. - regsource.com
Has regulatory affairs data, related federal register notices and links to clinical trials. Regulations and guidelines to NDA, ICH and GCP compliances offered
cder cber cdrh cfr fda ind nda irb generic drugs pharmaceutical otc over-the-counter clinical investigator clinical trial gmp good manufacturing practice glp goodlaboratory practice gcp good clinical practice drug approval
|
| |
|
Regulatory Affairs Consulting - newdrugapprovals.com
Regulatory affairs consulting services to the pharmaceutical and related industries
regulatory affairs regulatory approvals registration services regulatory agencies fda approval mca approval hpb approval regulatory services nda ide pma suitability petition dmf anda ndands ind 510k generic name registration usan application otc review
|