ApoTech Consulting (EUAR)
ApoTech Consulting
★★★★★
5.0
/ 5
•
73 reviews
Apotech Consulting offers expert life sciences and MedTech consulting, specializing in regulatory affairs, GxP audits, and quality management systems. They help organizations navigate complex global regulations for seamless compliance.
Apotech Consulting is a global industry expert dedicated to helping life sciences organizations streamline processes, mitigate risks, and adhere to complex industry regulations. They offer a modern and dynamic approach, providing regulatory peace of mind and confidence in compliance. Specializing in Pharma, Biotech, and MedTech sectors, Apotech provides tailored services including regulatory submissions (EU, FDA), medical writing, life cycle management, and GxP audits (GCP, GLP/GCLP, GVP, GMP/GDP, CSV). Their expertise ensures product quality, data integrity, and operational control throughout the product lifecycle. With a strong focus on quality, Apotech operates under an ISO 9001 Quality Management System, ensuring all projects meet the highest standards. They are committed to continuous improvement and helping clients achieve operational excellence and regulatory certainty in an ever-changing global landscape.
About
**Who they are**
ApoTech Consulting (EUAR) is a life sciences and MedTech consultancy firm founded by experts with a shared vision to address the unique and evolving needs of the industry. They specialize in regulatory affairs, GxP audits, and quality management systems, helping organizations navigate complex global regulations.
**Expertise & scope**
* EU Regulatory Submissions
* IVDR strategy for CE Marking and UKCA
* Guidance on regulatory requirements for medical software, including AI & diagnostics
* Scoping regulatory frameworks for market entry (e.g., GCC countries, US via CLIA)
* GxP Audits (GCP, GLP/GCLP, GVP, GMP/GDP, CSV)
* Quality Assurance (QMS Development, QP Services, RP Services, Mock Inspections, Training)
* Life Cycle Management
**Reputation / proof points**
* Focus on meeting and exceeding client requirements, with quality as a central business tenet.
* Commitment to continuous improvement through monitoring company processes and procedures.
* Understanding and respect for industry-specific rules and regulations.
ApoTech Consulting (EUAR) is a life sciences and MedTech consultancy firm founded by experts with a shared vision to address the unique and evolving needs of the industry. They specialize in regulatory affairs, GxP audits, and quality management systems, helping organizations navigate complex global regulations.
**Expertise & scope**
* EU Regulatory Submissions
* IVDR strategy for CE Marking and UKCA
* Guidance on regulatory requirements for medical software, including AI & diagnostics
* Scoping regulatory frameworks for market entry (e.g., GCC countries, US via CLIA)
* GxP Audits (GCP, GLP/GCLP, GVP, GMP/GDP, CSV)
* Quality Assurance (QMS Development, QP Services, RP Services, Mock Inspections, Training)
* Life Cycle Management
**Reputation / proof points**
* Focus on meeting and exceeding client requirements, with quality as a central business tenet.
* Commitment to continuous improvement through monitoring company processes and procedures.
* Understanding and respect for industry-specific rules and regulations.
Additional information
ApoTech Consulting emphasizes a client-centric approach, aiming to deliver services that not only meet but exceed expectations. Their quality policy is deeply integrated into their business operations, ensuring close monitoring of processes and procedures for continuous improvement. They are aware of and respect the applicable rules and regulations for suppliers within the life sciences and MedTech sectors. The firm's expertise extends to navigating international trade complexities, which remain a primary objective for many companies in these sectors, particularly in light of events like Brexit and global crises. They are equipped to address uncertainties and prepare for unforeseen events, ensuring a robust approach to regulatory compliance.
Key Highlights
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Specializes in regulatory affairs, GxP audits, and quality management systems for life sciences and MedTech.
Source
“Apotech Consulting offers expert life sciences and MedTech consulting, specializing in regulatory affairs, GxP audits, and quality management systems.”
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Provides guidance on regulatory requirements for medical software, including AI and diagnostics.
Source
“Guidance on regulatory requirements for medical software, including artificial intelligence & diagnostics”
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Offers IVDR strategy for CE Marking and UKCA.
Source
“IVDR strategy for CE Marking and UKCA”
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Assists with scoping regulatory frameworks for market entry into regions like the GCC countries and the US.
Source
“Scoping regulatory frameworks to enter the GCC countries Scoping regulatory frameworks to enter the US as an LDT, through the CLIA process”
Certifications & Trust Signals
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Quality is central to their business, with systems in place to ensure total customer satisfaction and development.
Source
“Therefore, quality is centric to our business. We also have systems in place to support our aim of delivering total customer satisfaction and development within Apotech.”
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Founded by individuals with nearly two decades of combined experience in life sciences consulting.
Source
“With nearly two decades of combined experience in life sciences consulting, they shared the same vision and wanted to create a life sciences consultancy company...”
Buyer Snapshot
Best for
- Companies seeking EU Authorized Representative services.
- MedTech and BioTech firms navigating complex global regulations.
- Organizations requiring support with IVDR and FDA compliance.
How engagement typically works
- Client-centric approach focused on exceeding expectations.
- Commitment to quality and continuous improvement.
- Proactive in addressing regulatory uncertainties.
Typical deliverables
- EU Regulatory Submissions
- IVDR strategy and CE Marking support
- Medical software regulatory guidance
- Market entry scoping
- GxP Audit support
- QMS Development
Good to know
- Best when requiring specialized life sciences and MedTech regulatory expertise.
HQ:
Paris, GB
Languages:
English, French
Timezones:
Europe/Paris
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
FR, BE, DE, NL
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
EUR 3,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports IVDR:
Yes
Device Classes Supported:
IVD
Post Market Support:
Yes
EU Entity Country:
EU
Supports MDR:
Yes
Labeling Review:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Supports MDR
true
Supports IVDR
true
