Regulatory Compliance Consulting

Avail our knowledge, tools, and resources to streamline your compliance journey and ensure your business stays in line with rapidly evolving regulations.

Leveraging

Extensive assistance in aligning your business with regulatory requirements: ISO 27001, ISO 13485, SOC II Type 2, GxP: GAMP 5, ASPICE, GDPR, NIS2, etc. We offer a complete guidance, from readiness assessment & strategy development to necessary components, processes, and procedures implementation.

Certified

Understanding of your existing compliance posture, a list of steps needed to meet regulatory requirements, and guidance along the roadmap implementation. All that delivered by one supplier, with no need to spend extra budget and time on growing in-house expertise to reach compliance with regulations.

WE ARE
0 YEARS

of Experience in Compliance Consulting
FEATURING

ISO 9001/27001

of Design & Development Experience

Our Clients Choose Us For

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Wide Expertise

Our regulatory compliance expertise covers diverse domains and industries.
From quality, cybersecurity, and privacy to healthcare and automotive sectors.

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Tailored Approach

Compliance strategy is unique for each case and depends on business specifics.
We create individual plans, carefully assessing action steps and changes needed.

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Cost Efficiency

We customize your change strategy, making it both efficient and budget friendly.
By applying our groundworks and maximizing the use of your current tech stack.

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Ongoing Support

We complement our compliance framework consulting services with ongoing support.
Our team monitors regulatory changes to timely optimize your compliance efforts.

Learn how our team would solve your business problem

Regulatory Compliance Services

Compliance Assessment

A wholescale assessment will give a holistic view of your compliance level and help accurately mark improvement areas for your future strategy. This approach eliminates the risk of budget outruns and increases the chances that your new framework will take hold and give the expected value.

Our compliance team uses custom criteria for benchmarking your current processes against regulatory requirements to safeguard a comprehensive and deep evaluation of your existing operations. This way, we can precisely identify the gaps and provide you with a detailed action plan that will help you achieve compliance in the shortest terms and with optimized resources.

Regulatory Requirements Implementation

Compliance with regulations may require additional expertise, especially when it comes to industries with intricate legal environments. The optimal solution in this case is to engage a competent external provider who will assist you with changes implementation and make sure they fully integrate into your operations.

At ETC Developer, we grew a center of excellence specializing in a wide range of regulations across diverse fields, including quality, privacy, cybersecurity, healthcare, automotive & more. Bringing together compliance, security, and technical expertise, our team will help you navigate the complexities of new requirements and guide you on how to apply them without disrupting your business operations.

Related Cases

Regulatory Compliance Project in 3 Steps

01

Assessment

As the first step, we assess your current compliance posture to plan further actions towards achieving your compliance with regulations requirements.

At this stage, we:

  • Perform audit of existing policies and processes
  • Identify and document areas for improvements
  • Plan and estimate the compliance project

02

Implementation

The next stage, our regulatory consulting experts will help you implement and adjust key processes based on the plan outlined in the earlier stage.

At this stage, we:

  • Evaluate and select the best-fit implementation options
  • Integrate necessary policies and procedures
  • Configure compliant processes across an organization

03

Support

Our support services include continuous regulations monitoring, their timely update, and recommendations on how to sustain regulatory compliance.

AAt this stage, we do:

  • Recurring processes, policies, and procedures audits
  • Consulting and advisory on compliance-related questions
  • Continuous tracking and updates on regulatory changes

Technologies We Work With

aspice

cppa

dora

eu annex11

fda

gdpr

gxp gamp5

hippa

iec 62304

iso 9001

iso 13485

iso 27001

nis 2

nist csf

soc2 type2

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