DESIGNERS OF INNOVATIVE QUALITY, REGULATORY & MARKET ACCESS SOLUTIONS

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DESIGNERS OF INNOVATIVE QUALITY, REGULATORY & MARKET ACCESS SOLUTIONS

About us

Strategiqual is a leading consultancy organization highly skilled for drugs, medical devices and cosmetics projects. We provide companies with a full range of innovative and customized services. Our assets/strengths: expertise, dynamism and reactivity. This is the spirit that allows us to offer high-quality and recognized services in the areas of regulatory affairs, market access, quality management and training.

About ProductLife Group:

Strategiqual is part of ProductLife Group (PLG) since 2023.
ProductLife Group’s mission is to support patient access to safe and effective healthcare solutions by delivering worldwide consulting and outsourcing services through the entire product life.
Thanks to PLG, and its global reach spanning more than 150 countries, Strategiqual can offer the Life Sciences Industries more services in the development, market introduction and life cycle management of product portfolios, and the related business and digital transformation.
With a goal of continuously improving the value delivered to teams and clients, PLG and Strategiqual are committed to long- term partnership, innovation, flexibility, and cost efficiency.
For more information about PLG, visit https://productlifegroup.com/

Our Team

You can rely on a team of 60 expert consultants to provide you with the support you need for your projects.

Discover the values and the team at :

Our Offices

Paris The historical presence of ou consulting and training team in the region.

Nantes Our new office at the service of the west region actors.

Lille The deployment of consultants in support of the North of France.

Toulouse A foothold in the South with our quality and regulatory consultants.

« Without imagination, there could be no creation » Albert JACQUARD

« Try not to become a man of success, but rather try to become a man of value » Albert EINSTEIN

« Leadership and learning are indispensable to each other » John F. KENNEDY

Our Solutions

Pharmaceutical industry
Medical Devices

Implementation and advocate of your quality system

Deployment of regulatory and quality as per GxP requirements
Implementation of risk management process within the organization
Expertise in the distribution and shipping of drugs: audit, shortage management plan
Quality, pharmaceutical and vigilance processes audit
Customized training programs for pharmacists

Crisis management and inspection strategy

Strategic and operational preparation to inspections
Chief Pharmaceutical Officer and auditees coaching
Strategic and knowledge report in BCP/IMP for pharmaceutical sites
Crisis management in relation to Health Authorities decisions
Transition management and external Chief Pharmaceutical Officer deputy functions

Scientific promotional materials: Certification Facilitator

Strategic organization of promotional activities and scientific information
Full support in your HAS certification project
Mock audits of your promotional system and related providers and subcontractors
Training and coaching of Certification involved teams
Assessment of Ethics and Compliance regarding Processes & Transparency

Boost your clinical and regulatory strategy

Regulatory and market access strategies: EU, USA and Canada
Pre-clinical and clinical investigation and development strategies
Technical Files, PMA and 510(k)
E-Health, software and computerized system validation
Efficient transition strategy to the new European regulation (MDR)

Reimbursement

Health technology assessment for innovative technologies
Customized reimbursement strategies for EU key countries (coding and payment investigation, gap analysis, timelines, etc).
Value dossiers for France and Belgium (LPPR and INAMI)
Training covering principles of medical devices market access in Europe
Meeting/interviews with key-decision makers (health authorities and payers) and KOLs

Quality Management and Inspection by Regulatory Authorities

Implementation of Quality Management Systems according to EN ISO 13485 and 21 CFR part 820
Preparation to Health Authorities (ANSM, FDA, ANVISA, etc) and Notified Bodies inspections
Control of advertising and sales promotion
Customized regulatory, technical and clinical monitoring
French Sunshine Act («DMOS»)

These companies have trusted us and are still doing so

ABBVIE
ADVICENNE
AINOS
ALEXION
ALMIRALL
AMBU
AMGEN
ASTELLAS
ASTRAZENECA
AXAMED
B.BRAUN
BASECAMP VASCULAR
BAUSCH ET LOMB
BAYER
BFORCURE
BIOGARAN
BIOGEN
BIOLOGICS 4 LIFE
BIOMATLANTE
BIOSERENITY
BMS
BOTDESIGN
BOUCHARA - RECORDATI
BRACCO
BRAINTALE
Boehringer Ingelheim
CALIMED SANTE
CCD
CELGENE
CHAUVIN
CHUGAI
CLOVIS ONCOLOGY
CSL BEHRING
DAIICHI SANKYO
DEDALUS
DENSMORE
DIFFULICE
EFELYA
EISAI
ENGIE
ETHIMEDIX
ETHYPHARM
EUTELMED
EXELTIS SANTE
EXPANSCIENCE
FDE
FDG GROUP
FERRING
FRANCE CHIRURGIE
Fresenius
GE Healthcare
GENOMIC VISION
GRIFOLS
Galapagos
Genbiotech
Graftys
HANES
HRA-PHARMA
I-SEP
IN' SURG
INNOTECH
INNOVHEM
INOREVIA
INTELLIGENCE ANESTHESIA
IPSEN
Innothera
JELLYNOV
KIBION
KYOWA KIRIN
KeriMedical
LARS
LEO PHARMA
LFB BIOMEDICAMENTS
LUCINE
LUNDBECK SAS
MEDICEN
MEDTRONIC
MENARINI
MERZ
MICROVENTION
MIS
MSD
MYLAN
Mastor Surgical
Micrel
Minvasys
Mobidiag
Mundipharma
NEOSPER
NEURADOM
NEURALTIDE
NEURAXPHARM
NORGINE
NOVO NORDISK
NUREA
OPEN STENT SOLUTION
ORGANON
ORPHELIA
OTSUKA
PAIRE
PEGASE
PERIFIT
PFIZER
PRECIPHAR
Paris Biotech Sante
Pentaferte
ROCHE DIAGNOSTICS
SANTEN
SERVIER
SG PHARM
SHIRE FRANCE
SONOSCANNER
SORIN
SUBSTIPHARM
SUN PHARMACEUTICAL
SWEDISH ORPHAN BIOVITRUM
SYNAPSE MEDICINE
SYSNAV
Sirtex
TAKARA BIO
TAKEDA
TECHNI PHARMA
THEA PHARMA
THERABEL
THERADIAL
TISSUEAEGIS
Teva
Tillotts
Traaser
UCB
UFOP
UPSA
Visiomed
Vyaire
WEFIGHT
X.O
YNCREA
ZAMBON
ZYDUS

Nos certifications

ISO 9001:2015 Certified

Quality Management System

ISO 13485:2016 Certified

Medical Device Quality Management System

ISO 14001:2015 Certified

Environmental management

QUALIOPI

Certification of Training Actions

DPC

Continuous Professionnal Development

>500

500 clients since the creation of STRATEGIQUAL. The turnover is in average +40% every year.

>100

100 inspections and certification audits successes

60

60 incredible consultants

100%

100% of our activities is performed internally and 100% of our consultants are highly motivated!

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CONTACT

Strategiqual - ProductLife Group

Immeuble Colisée Gardens, 10 Av. de l'Arche Bâtiment C, 7ème étage, 92400 Courbevoie, France

Recruitment

RECRUITMENT

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