Validation & Qualification
Computer System Validation
Data Integrity
Process Validation
Cleaning Validation
Equipment Qualification
Facilities Commissioning & Qualification
Aseptic Remediation and Operations Evaluations
Trusted Services
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Well Experienced
15 years of experienceOur Services
We provide the best services
Quality and Compliance Services
Quality Systems Implementation
FDA Warning Letter/483 Remediation
FDA Readiness Inspections / Mock Audits
Quality System Audits / GAP Assessments
IT and Supplier Audits
CAPA, Deviation & Complaint Inv/Closeout
Regulatory Compliance Services
M&A Compliance / Due Diligence
Technology Transfer
Laboratories
Training and Project Management
Program & Project Management
Rapid Project Startup Services
Project Management Training
cGMP Training
Customized Training Programs
EGULATORY AFFAIRS AND OPERATIONS
dossiers, Novagenx provides:
1-Early-stage regulatory operations, including applying for application numbers, filing an intent to submit applications, meetings and briefing packages support, and advisory meetings
2-Clinical development regulatory operations and global submissions of study authorization applications, including initial study applications and amendments; scientific advice submissions; special designation submissions like fast-track designation, and special protocol assessment requests
3-Marketing authorization and post-approval life-cycle management, including initial marketing authorization applications or amendments and the maintenance of approved marketing applications.
CLINICAL DATA MANAGEMENT
-An experienced team to help manage studies across a variety of industry standard EDC platforms;
-Expertise to recommend and deploy cutting-edge “e” or electronic technologies including ePRO, eCOA and eConsent with minimal expense and no disruptions;
-A wide range of therapeutic area experience;
-proven processes to begin clinical studies faster, with accurate, clean results more quickly;
near real-time access to clean clinical data; and
-A single point of contact, allowing sponsors to spend less time managing vendors and more time on trial analysis and insights
Recruitment Solutions
HELPING OUR PARTNERS TO SOURCE, ENGAGE AND MOBILIZE HIGH-CALIBER PROFESSIONALS FOR SPECIALIST VACANCIES ACROSS THE GLOBE