website creation software
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We believe in simple values
that reflect who we are!

We believe that being ethical is about doing the right thing for the right reasons.

We believe that commitment is a willingness to give your time and energy to something
that you believe in.

We believe that being reliable means that you do what you promised to do.

We believe that working together toward a common vision is the key success.

Our values are at the core of our daily business and we’ve always let these values guide us through every mission.

We work hard to understand the organisations we work with.
We understand the problem our clients are trying to solve, and we bring ideas that may not have been considered before.

Through our decades of experience in the Pharma industry,  we understand  

that the product development cycle for the Pharma sector is a long-drawn process and that the industrial operations and products distribution for the Life Sciences sector are agile processes evolving with the regulations and the business environment.

We are committed to offering technical guidance for sourcing strategies, 3rd party-management, QA compliance and project management.

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EXPERTISE

To drive superior Supply Chain performance and competitiveness.

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Outsourcing.

Request For Quotation (RFQ)
Suppliers and contract manufacturers identification, due diligence and selection
Agreements : supply chain, quality, service level
Performances measures
Technology transfer of know-how
Mapping of flows and design of sourcing processes 


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Projects.

Track & Trace and serialization
Production transfer
New product introduction, roll-out
Up-grading of facilities
Packaging development
Equipment qualification and Computer System Validation (CSV)


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HR Workshops.

Assessment of your teams competencies
Team coaching
Mentoring
Training: leadership skills, Train the Trainer
E-learning : development of innovative solutions according to your needs
Governance & Diversity; Governance & Digital


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QA Compliance.

Quality Management Systems (QMS) management
Assessment & gap analysis of your QMS
Track & Trace and serialization
Audits: contract manufacturers (CMO), wholesalers, third-party logistics
Validation: computer systems, transportation
QA intelligence : GMP / GDP - ISO 9001 - ISO 13485 - ISO 14001


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Regulatory Affairs RA. 

> Middle East Countries (Lebanon, Jordan, Syria, GCC countries)


Drugs
Gap analysis of registration files according to regulatory requirements.
New Registrations (CTD- e-CTD) and maintenance activities for manufacturing sites and products  

Cosmetics
E-cosma in KSA, Dubai Municipality (DM) and Emirates Authority for Standardization and Metrology (ESMA)

Medical Devices and Food Supplements
New registrations and maintenance activities 

Vigilances
Setting up a vigilance system, PBRERs (Periodic Benefit Risk Evaluation Reports) submissions, signal detection, Pharmacovigilance System MasterFile 
Reviewing of SDEAs (Safety Data Exchange Agreements)

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Regulatory Affairs RA. 

> Switzerland and European Countries


Cosmetics
Security evaluation (Parts A & B)
PIF (Product Information File) file constitution.
CPNP (Cosmetic Products Notification Portal) notification

CBD
Cannabis medical and/or cosmetic use expertise

Medical Devices
CE file constitution - Support to Notified Body relations

Food Supplements
New registrations and maintenance activities in European countries.
New registrations and maintenance activities in Switzerland. 


The quality of our team is our key strength.

Our consulting team spans multiple generations and crosses a wide variety of experiences and areas of expertise.

We are entrepreneurs, innovators, academic professors and speakers that come from executive positions in different industries.

During the past 15 years we have carried out assignments for pharma companies in Europe and the Middle East.

We've always approached every project as a unique partnership, looking beyond the traditional services to deliver support to project teams with mapping of processes in operations and procurement,

We believe that devoting yourself to something with passion is the key to success.

Nathalie Wardé
Managing director & Sr. consultant

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PROCESS

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Listen.

Providing global consulting that meets your objectives starts with listening very carefully to your current and future objectives.
The correct assessment at this stage is critical to delivering faster, better, smarter results for your organization.


Analyse.

Once we’ve gathered all the relevant information our in-house experts can analyze your situation. Our team’s expertise in Pharma consultancy draws upon decades of high level experience working across the EMA regions.


Propose.

Having shared and reviewed our analysis with you, we’ll propose a solution to meet your requirements, a solution built around our expertise.



Roll-out.

Once we’ve developed and agreed on the best approach for your needs, we leverage our in-house capabilities, our external experts and our network to deliver on the execution.

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Our process is based
on a simple goal :
Make you reach yours!

CORPORATE EDUCATION
IN-HOUSE PROGRAM

All kinds of learning scenarios can be
successfully implemented.



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TRAINING

OUR IN-HOUSE
TRAINING PROGRAM

TAILORED TO YOUR NEEDS.

INTRODUCTION TO GMP (GOOD MANUFACTURING PRACTICE)
---
GDP (GOOD DISTRIBUTION PRACTICE) :
TRANSPORTATION VALIDATION / GDP FOR 3PL AND HAULIERS
---
INTRODUCTION TO DRUG PRODUCTS TRACEABILITY
ACCORDING TO THE EU FMD - FALSIFIED MEDICINE DIRECTIVE
---
TRACK & TRACE : SHARING BEST PRACTICES
HOW TO AUDIT THE SYSTEMS IN PLACE FROM COMPLIANCE
TO NEW BUSINESS OPPORTUNITIES
---
LIFE SCIENCES : SECURE YOUR SUPPLY CHAIN
---
DATA MANAGEMENT : BUILD YOUR PRODUCT DATA SHEET (DRUG PRODUCTS & MEDICAL DEVICES)


Languages :  Français  /  English 

MANAGEMENT OF THIRD PARTY MANUFACTURERS
CDMO (CONTRACT DEVELOPMENT AND MANUFACTURING ORGANIZATION) BEST PRACTICES
---
QUALITY AGREEMENTS
---
PURCHASING IN THE PHARMA SECTOR
---
SOURCING IN THE PHARMA SECTOR


Languages : Français / English 
 

PACKAGING DEVELOPMENT :
HOW TO CONCILIATE MARKETING, TECHNIQUE AND REGULATIONS
---
COSMETICS : REGULATION (EC) NO 1223/2009
CONSTITUTION OF THE PIF FILE (PRODUCT INFORMATION FILE)
REGISTRATION - CPNP PORTAL (COSMETIC PRODUCT NOTIFICATION PORTAL)
---
MD AND MARKING - EC
MEDICAL DEVICES CLASSIFICATION RULES
SETTING UP OF THE MARKING FILE - EC
---
MEDICAL DEVICES (MD) :
ARE YOU READY FOR UDI (UNIQUE DEVICE IDENTIFICATION) ?
---
ENVIRONMENT :
HOW TO COMPLY WITH ISO 14001  
---
VIGILANCE :
IN MIDDLE EAST COUNTRIES (PHARMACOVIGILANCE, COSMETOVIGILANCE, NUTRIVIGILANCE, MATERIOVIGILANCE)
ELABORATION OF VIGILANCES TRAININGS ON LOCAL REQUIREMENTS 


Languages : Français / English 

"PUT THE HUMAN PERFORMANCE IN THE HEART OF PROJECT MANAGEMENT"

THE FUNDAMENTALS OF PROJECT MANAGEMENT APPLIED TO THE DEVELOPMENT OF NON-PHARMACEUTICAL HEALTH PRODUCTS (FOOD SUPPLEMENT, COSMETICS, OTC-US)
---
IMPLEMENTATION OF THE HERMÈS METHOD
---
THE KEYS TO THE SUCCESS OF YOUR PROJECT MANAGEMENT AND THE ROLE OF THE PROJECT MANAGER
---
MANAGE THE VALIDATION OF YOUR INFORMATION SYSTEMS IN PROJECT
---
TALENT ACQUISITION AND DEVELOPMENT
---
KEYS TO TRANSVERSAL COMMUNICATION & PROJECT COMMUNICATION MATERIALS
---
ALIGNING PROJECTS WITH THE COMPANY STRATEGY
---
LEADERSHIP AND HORSE COACHING °
---
TEAM AND STRESS MANAGEMENT °
---
SELF AWARENESS 


  Languages : Français / English 
° Language : Français 

SUCCEEDING IN YOUR FMEA (Failure Mode Effects Analysis)
 ---
ISHIKAWA DIAGRAM / 5M METHODOLOGY
---
SMED  (SINGLE MINUTE EXCHANGE OF DYE)
---
BRAINSTORMING 5S  WORKSHOP


Languages :  Français / English

For more information and details about our training programs



Our team is composed
of experts in the Life Sciences Sector.
We have developed a unique model with experts in different fields.

Meet our team of experienced consultants

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CLIENTS

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In Europe and the Middle East

The companies with whom we have been cooperating for years are diverse, but all of them are characterized by their high standards of performance and quality. 
It is a privilege for us to be able to work for companies recognized as leaders in their field.
Over the years, they continue to believe in our passion and commitment to excellence.
We are honoured to be able to contribute at our level to their success.






JOIN OUR MONTHLY
FREE WEBINARS

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EVERY LAST FRIDAY
OF THE MONTH

STARTING 11 AM
30' + 10' Q&A

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PARTNERS

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DO NOT HESITATE TO GET IN TOUCH ! 

Your NAD Consulting team

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