Apotech Consulting
★★★★★
5.0
/ 5
•
73 reviews
Apotech Consulting provides comprehensive regulatory representative services for medical devices, IVDs, and cosmetics. They offer UK Responsible Person (UKRP), EU Authorised Representative (EUAR), Person Responsible for Regulatory Compliance (PRRC), and representative services in other countries. With global expertise spanning UK, EU, and US markets, Apotech helps manufacturers ensure regulatory compliance and market access.
Apotech Consulting is a global life science regulatory consulting firm specializing in representative services for medical devices, in vitro diagnostics (IVD), and cosmetic products. They provide UK Responsible Person (UKRP) services for UK market access, EU Authorised Representative (EUAR) services for EU market access, and Person Responsible for Regulatory Compliance (PRRC) services. Apotech has helped over 120 MedTech and IVD manufacturers navigate global regulations. Their services include device registration, regulatory oversight, technical documentation management, market surveillance, incident reporting, and serving as the point of contact with regulatory authorities. With consultants available in every major global country, Apotech offers tailored advice and guidance to represent manufacturers worldwide.
About
**Who they are**
Representative Services, operating as Apotech, is a consultancy firm established to address the evolving needs of the life sciences industry. Founded by individuals with nearly two decades of combined experience in life sciences consulting, Apotech focuses on providing tailored solutions.
**Expertise & scope**
* GxP Audit Services (GCP, GLP/GCLP, GVP, GMP/GDP, CSV)
* Quality Assurance (QMS Development, QP Services, RP Services, Mock Inspections, Training)
* Regulatory Affairs (EU Regulatory Submissions, Medical Writing, FDA Submissions, Life Cycle Management)
* MedTech product quality and compliance improvement
* Risk-based approaches to quality and compliance
**Reputation / proof points**
* Founded by experienced life sciences consultants.
* Focus on international trade and global regulatory expectations.
Representative Services, operating as Apotech, is a consultancy firm established to address the evolving needs of the life sciences industry. Founded by individuals with nearly two decades of combined experience in life sciences consulting, Apotech focuses on providing tailored solutions.
**Expertise & scope**
* GxP Audit Services (GCP, GLP/GCLP, GVP, GMP/GDP, CSV)
* Quality Assurance (QMS Development, QP Services, RP Services, Mock Inspections, Training)
* Regulatory Affairs (EU Regulatory Submissions, Medical Writing, FDA Submissions, Life Cycle Management)
* MedTech product quality and compliance improvement
* Risk-based approaches to quality and compliance
**Reputation / proof points**
* Founded by experienced life sciences consultants.
* Focus on international trade and global regulatory expectations.
Additional information
Apotech Consulting emphasizes a risk-based approach to improve quality and compliance for MedTech products. Their scalable approach allows them to work effectively with a wide range of companies, from research and development stages through to manufacturing and distribution. They aim to provide clear insight, reduced risk, and enhanced inspection readiness, delivering regulatory peace of mind and confidence in compliance. Buyers can engage Apotech for practical solutions designed to deliver results in a complex global regulatory landscape.
Key Highlights
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Specializes in GxP audit services, covering GCP, GLP/GCLP, GVP, GMP/GDP, and CSV.
Source
“GxP audits provide a structured, independent assessment of systems, processes, and vendors to verify compliance with Good Practice regulations, including GCP, GLP & GCLP, GVP, GMP/GDP, and CSV.”
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Offers comprehensive Quality Assurance services including QMS Development, QP Services, RP Services, Mock Inspections, and Training.
Source
“Quality AssuranceQMS DevelopmentQP ServicesRP ServicesMock InspectionsTraining”
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Provides Regulatory Affairs support, including EU and FDA Submissions, Medical Writing, and Life Cycle Management.
Source
“Regulatory AffairsEU Regulatory SubmissionsMedical WritingFDA SubmissionsLife Cycle Management”
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Helps companies maintain compliance with ICH guidelines and global health authority standards such as FDA, EMA, and MHRA.
Source
“Our GxP audit services help biotech and pharmaceutical companies maintain compliance with ICH guidelines and global health authority standards, including the FDA, EMA, and MHRA.”
Certifications & Trust Signals
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Founded by industry experts 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...”
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Dedicated to meeting and exceeding customer requirements, with quality as a central focus.
Source
“At Apotech, we are fully aware that the patient is the ultimate stakeholder of our projects, so we are dedicated to meeting all of our customer’s requirements.”
Buyer Snapshot
Best for
- Life sciences and MedTech companies seeking GxP audit and compliance support.
- Organizations needing assistance with regulatory submissions and quality management systems.
How engagement typically works
- Consultative partnership to streamline quality processes.
- Risk-based approach to compliance and product quality.
Typical deliverables
- GxP Audit Reports (GCP, GLP/GCLP, GVP, GMP/GDP, CSV)
- QMS Development and Implementation
- Regulatory Submission Support (EU, FDA)
- Mock Inspections and Training
- Quality Assurance Services
Good to know
- Best when seeking expert guidance on complex global regulatory expectations in the life sciences sector.
HQ:
Washington, US
Languages:
English
Timezones:
EST
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
UK
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
7–21 days
Pricing model:
Custom pricing
Supports GB:
No
Supports NI:
No
MHRA Support:
No
Can Be Named On Label:
No
MHRA Portal Support:
No
Vigilance Support:
No
Additional uk_rp Details
Supports MDR
true
Supports IVDR
true
Supports GB
true
Vigilance Support
true
UK Entity Country
England
