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.
• 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
• Track & Trace and serialization
• Production transfer
• New product introduction, roll-out
• Up-grading of facilities
• Packaging development
• Equipment qualification and Computer System Validation (CSV)
• 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
• 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
> 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)
> 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.
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
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.
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.
Having shared and reviewed our analysis with you, we’ll propose a solution to meet your requirements, a solution built around our expertise.
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.
INTRODUCTION TO GMP (GOOD MANUFACTURING PRACTICE)
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GDP (GOOD DISTRIBUTION PRACTICE) :
TRANSPORTATION VALIDATION / GDP FOR 3PL AND HAULIERS
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INTRODUCTION TO DRUG PRODUCTS TRACEABILITY
ACCORDING TO THE EU FMD - FALSIFIED MEDICINE DIRECTIVE
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TRACK & TRACE :
SHARING BEST PRACTICES
HOW TO AUDIT THE SYSTEMS IN PLACE FROM COMPLIANCE
TO NEW BUSINESS OPPORTUNITIES
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LIFE SCIENCES : SECURE YOUR SUPPLY CHAIN
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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
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QUALITY AGREEMENTS
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PURCHASING IN THE PHARMA SECTOR
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SOURCING IN THE PHARMA SECTOR
Languages : Français / English
PACKAGING DEVELOPMENT :
HOW TO CONCILIATE MARKETING, TECHNIQUE AND REGULATIONS
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COSMETICS : REGULATION (EC) NO 1223/2009
CONSTITUTION OF THE PIF FILE (PRODUCT INFORMATION FILE)
REGISTRATION - CPNP PORTAL (COSMETIC PRODUCT NOTIFICATION PORTAL)
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MD AND MARKING - EC
MEDICAL DEVICES CLASSIFICATION RULES
SETTING UP OF THE MARKING FILE - EC
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MEDICAL DEVICES (MD) :
ARE YOU READY FOR UDI (UNIQUE DEVICE IDENTIFICATION) ?
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ENVIRONMENT :
HOW TO COMPLY WITH ISO 14001
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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)
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IMPLEMENTATION OF THE HERMÈS METHOD
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THE KEYS TO THE SUCCESS OF YOUR PROJECT MANAGEMENT AND THE ROLE OF THE PROJECT MANAGER
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MANAGE THE VALIDATION OF YOUR INFORMATION SYSTEMS IN PROJECT
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TALENT ACQUISITION AND DEVELOPMENT
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KEYS TO TRANSVERSAL COMMUNICATION
& PROJECT COMMUNICATION MATERIALS
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ALIGNING PROJECTS WITH THE COMPANY STRATEGY
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LEADERSHIP AND HORSE COACHING °
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TEAM AND STRESS MANAGEMENT °
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SELF AWARENESS
Languages : Français / English
° Language : Français
SUCCEEDING IN YOUR FMEA (Failure Mode Effects Analysis)
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ISHIKAWA DIAGRAM / 5M METHODOLOGY
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SMED (SINGLE MINUTE EXCHANGE OF DYE)
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BRAINSTORMING / 5S WORKSHOP
Languages : Français / English
