REGULATORY COMPLIANCE & INSPECTION
At RegScript, we understand the challenges businesses face when it comes to
navigating
the
complex landscape of Regulatory Compliance.
We have tailored solutions to help you establish the implications of regulatory
compliance for
your products, services, and systems across different geographical contexts, as well as simplifying the
process
of interfacing with Market Surveillance Authorities and Certification Bodies, Approved Bodies and
Notified
Bodies responsible for Product Conformity Assessment, driven by the applicable laws for each region.
RegScript PE provides Regulatory Advisory and Compliance Solutions for the
Certification
of Pressure Equipment by Manufacturers, Importers, Distributors, End Users and Plant Owners
according
to:
• UK PESR - Pressure Equipment (Safety) Regulations 2016 (UKCA),
• EU PED - Pressure Equipment Directive (PED 2014/68/EU) (CE Mark),
• UK TPER - Transportable Pressure Equipment Regulations (ρ Mark),
• EU TPED - Transportable Pressure Equipment Directive (π Mark),
• US ASME and DoT
We know that navigating the requirements of the Pressure Equipment Directive
(PED/PE(S)R) is a significant challenge. The path to achieving a compliant UKCA or CE mark is complex,
expensive, and fraught with potential for costly delays.
While approaching a Notified or Approved Body directly seems like the logical first
step, it often leads to an inefficient and frustrating process. A Notified Body's role is to be an
impartial assessor, not a consultant. They can tell you that you have failed, but they cannot tell you
how to fix it.
This is where RegScript provides a distinct and powerful advantage. Our role is to act
as your strategic partner, ensuring you are perfectly prepared for a smooth, successful, and
cost-effective certification process.
Why engage with us first?
Cost-Effectiveness by Design: Our process is designed to be highly
cost-effective by ensuring your technical file and design validation are right the first time. We
help you avoid the expensive delays, re-submission fees, and engineering rework that unprepared
applications almost always incur.
Clarity and Control with Our Proprietary Platform:
We provide you with access to our dedicated digital platform. This provides a clear, step-by-step
roadmap for building your technical file, ensuring no document is missed and that your team
understands exactly what is required at every stage.
Access to Proactive Consultancy: Crucially, we can provide the proactive
technical and regulatory advice that Notified Bodies are prohibited from offering. Our wider network
of
specialist associates can provide expert advisory on everything from M&E Engineering to advanced
materials, ensuring any potential issues are solved long before your formal submission.
Holistic, Multi-Disciplinary Expertise: Notified Bodies are limited to their
specific scope of accreditation. We are not. We can assess your product holistically—covering the
pressure systems, the quality assurance aspects, electrical safety, and more—to build a single,
coherent
compliance strategy from the start.
Our goal is to de-risk the entire certification journey for you, making it faster,
more
predictable, and ultimately more successful.
That's why we've developed a cutting-edge online platform to streamline the process,
simplify
compliance requirements, and empower you to meet regulatory standards with confidence.
Regulatory Advisory and our step-by-step guidance Web App are solutions designed to
be
your one-stop destination for all things related to understanding and navigating the complex field
of
Pressure Equipment Compliance and Certification.
Sign up by creating an account. Once logged in, you'll receive a full 30-day
subscription and a set of free project tickets, which you may use as you wish.
Please feel free
to contact us for a discussion. Following that, we can prepare a preliminary proposal outlining a clear
and cost-effective pathway to UK and EU market access for your products.
RegScript Developments LTD
Regulatory Compliance Services
Registered in
United Kingdom
Reg. No.
VAT
15234027
GB466195756
Designed by
RegScript@2023