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.

Assistance in aligning your business with regulatory requirements

What We Do
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.
What You Get
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.

Leveraging

12 Years

of Experience in Compliance Consulting

Certified

ISO 9001/27001

Lead Implementors and Auditors

Our Clients Choose Us For

Wide Expertise

Our regulatory compliance expertise covers diverse domains and industries.

From quality, cybersecurity, and privacy to healthcare and automotive sectors.

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.

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.

Ongoing Support

We complement our compliance framework consulting services with ongoing support.

Our team monitors regulatory changes to timely optimize your compliance efforts.

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 Sigma Software, 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

Building OWASP-Compliant Application Security Framework For CGM

We assessed 260 СGM services, helped the Client improve their security framework according to OWASP SAMM, DSOMM & ASVS standards, and set up a real-time security monitoring process.

Regulatory Compliance Project in 3 Steps

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

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

Support

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

At this stage, we do:

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

Standards and Regulations
We Help Comply with

ISO 9001:2015

ISO/IEC 27001:2022

ISO 13485:2015

SOC II Type 2

GxP: GAMP 5

IEC 62304

ASPICE

GDPR

HIPAA

NIS 2

DORA

CPPA

FDA Title 21

NIST CSF

EU Annex 11

Our RTP philosophy and vision

Reliability

Focus on helping you achieve your business goals - both current and long-term
Battle-tested processes ensuring uninterrupted service & robust quality control
Rigid quality control with a range of KPIs to track delivery quality and efficiency

Transparency

Regular status updates & reporting at different management levels
Clear, predictable, and consistent billing with full expenditure reports
PM tools of your choice (Jira, Confluence, Azure DevOps) & clear project flow tracking

Partnership

Tailor-made solutions & focus on delivering value, not just performing the tasks
Finding new ideas & the most effective solutions for your individual case
Continuous optimization and enhancement of service delivery & performance