DANOPI PHARMA CONSULTANCY

Timely delivering full compliance and cost effective solutions 

Who we are
A client focused global consultancy company, based on +30 years regulatory body experience and GxP global industry expertise, including delivery of successful multiple approvals by EU/ US-FDA / PMDA / ANVISA / HC / TGA / MoIT / GCC.

Main areas of expertise: Quality Systems, Validation, sterile manufacturing (aseptic filling, terminal sterilization, lyophilization), SODs manufacturing, API manufacturing, IPC/Release/Stability testing (chemical and micro), Environmental and personnel monitoring, GMP equipment, facilities and critical utilities qualification, GxP audits, data integrity, project management, inspection readiness and remediation 

Our emphasis is to always deliver on-time customized solutions and outstanding affordable services in full compliance with all relevant regulations.

Services

GxP Consultancy

Worldwide approved Quality Systems: Design, implementation, compliance, continuous improvement and remediation

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GxP Audit

API suppliers, CMO, CROs audit. Inspection readiness plan and execution. Mock inspections

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GxP Training

Worldwide GxP Regulations, Quality Systems, Testing, Validation, Engineering

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Regulatory and EU QP Services

Regulatory support Documentation review EU release

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Technical & Analytical Support

Equipment, facilities, utilities qualification, Cleaning and Process Validation, Analytical support and validation

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Quality Systems
Quality Systems 
independent review and improvement, 
in full compliance with worldwide GxP regulations 

Quality Control 
independent review and improvement support 
Chemistry & Microbiology Laboratories

Manufacturing, Facilities and Utilities 
review and improvement, focus on sterile manufacturing and SOD 

GxP inspection readiness 
management, mock inspection, remediation
deficiency letters response support 

Quality Improvements support
compliant and effective solutions, plan and execution

GxP Documentation 
building, independent review, improvement 

Remote services
GxP support, audit
e-learning (tours, coaching, multiple experts in augmented reality).
Suppliers Audit, Training,  
Regulatory & QP Services
Suppliers audits vs worldwide GxP regulations 
APIs, excipients, packaging materials, storage sites, 
services, manufacturing and testing sites

GxP Training 
Quality System Managenent
GxP Documentation
EU/US-FDA/PMDA regulations for Quality Systems, 
Quality Control
APIs, SODs & Sterile Manufacturing
Qualification, Calibration
Cleaning and Process Validation
Data Integrity 

Inspection readiness preparation, Mock inspections 
vs worldwide regulations: ICH / PICs / WHO / EMA / 
FDA / PMDA / TGA / HC / MoIT / GCC / ANVISA

EU QP services: 
QP documentation review & QP EU Release

Regulatory Services: 
Applications review & life cycle management
TECHNICAL SUPPORT 
Commissioning, Validation, Calibration and Qualification

1. Equipment, facilities and utilities 
protocols, execution & reports (FAT/SAT/DQ/IQ/OQ/PQ) 
2. Cleaning validation, Sterility validation, Process validation 
Continuous Process Verification 
3. GxP support for facilities and utilities 
manufacturing and analytical equipment, 
clean rooms, AHUs, water systems etc


ANALYTICAL SUPPORT  

1. Analytical methods 
development and validation 
Customized Analytical Studies (supply chain validation)
2. Specifications 
In-process controls, Release, Shelf Life, Stability (ICH)
3. Ready-to-use analytical laboratories 
laboratory, expertize, instruments, 
reagents and consumables

Contact

  • Nades Street 30B, 013334 Bucharest, Romania

Mission

"Quality is never an accident" John Ruskin

 There is no greater challenge and opportunity to make a meaningful and reliable difference. We commit to develop and consistently execute all projects on time, in full compliance with relevant GxP regulations, effectively and consistent, in order to offer new hope and help to patients. Our vision is to continue proving be a leader focus on a better life and we see this mission as a moral responsibility. 

Dan Napradean Ph.D.