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.
Regalutory Compliance Specialist
12  Years

of Experience in Compliance Consulting

 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.

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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 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.

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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

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
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
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
Technologies for Regulatory Compliance

Standards and Regulations
We Help Comply with

ISO 9001:2015
ISO/IEC 27001:2022
ISO 13485:2015
SOC II Type 2
IEC 62304
FDA Title 21
EU Annex 11
Misty Mountains

Our RTP philosophy and vision


  • 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


  • 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


  • 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
Regulatory Compliance Expert
Let us discuss how our team can contribute to your success

Our Offices

Munich, Germany

Design Offices München Atlas, Rosenheimer Str. 143C, 81671 Munich, Germany
Nurnberg, Germany

Design Offices Nürnberg City, Königstorgraben 11, 90402 Nürnberg, Germany
Poltava, Ukraine

Sobornosti Street, 46В, Poltava, Poltava Oblast, Ukraine
Cherkasy, Ukraine

Sigma Software, Cherkasy Office
Priportova Street, 22A, Cherkasy, Cherkasy Oblast, Ukraine
Sao Paulo, Brasil

Sigma Software, Brazil office
Rua Purpurina, 400, 7º Floor, Vila Madalena, São Paulo, Brazil

(11) 3197-0269
Lisbon, Portugal

Sigma Software, Lisbon Office
Rua da Junqueira 218/220 R/C 1300-598, Lisbon
Budapest, Hungary

Budapest Office, Közraktár u. 30-32, Building K30, 1093 Budapest, Hungary
Sofia, Bulgaria

Sigma Software Sofia
bulevard "Cherni vrah" 51, 1407 Promishlena zona Hladilnika, Sofia, Bulgaria
Burgas, Bulgaria

Sigma Software Sofia
bulevard "Cherni vrah" 51, 1407 Promishlena zona Hladilnika, Sofia, Bulgaria
Ivano-Frankivsk, Ukraine

Sigma Software, IF Office
Nadrichna St, 6, Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

+38 (050) 782 47 67
Prague, Czech Republic

Sigma Software, Prague Office
Evropská 11/2758, Praha 6, Česká republika
Krakow, Poland

Sigma Software, Krakow Office
Wadowicka 7, 30-347 Kraków, Poland
Poznan, Poland

Sigma Software, Poznan Office
Zwierzyniecka 3, Concordia Design, 60-813 Poznań, Poland
Lutsk, Ukraine

Sigma Software, Lutsk Office
Artseulova St, 2, Lutsk, Volyn Oblast, Ukraine
Uzhgorod, Ukraine

Sigma Software, Uzhhorod Office
Bohomol'tsya Street, 21, Uzhhorod, Zakarpattia Oblast, Ukraine

+38 (067) 742 06 29
Ternopil, Ukraine

Sigma Software, Ternopil Office
15 Kvitnya Str., 2m, Ternopil, Ternopil Oblast, Ukraine

+380 (67) 350 96 63
Cascais, Portugal

Sigma Software, Cascais Office
office 1.23, Estr. Malveira da Serra 920, 2750-834 Cascais, Portugal
Chernivtsi, Ukraine

SIgma Software, Chernivtsi Office
Storozhynetska 25, 2 floor, Chernivtsi, Chernivtsi Oblast, Ukraine

+38 (067) 287 41 13
Buenos Aires, Argentina

Avenida del Libertador 1000, Vicente López, Buenos Aires Province, Argentina

Mexico City, Mexico

Av. Paseo de la Reforma 296, Juárez, 06600 Ciudad de México, Mexico City, Mexico

Medellin, Colombia

Business District Golden Mile, Calle 4 Sur, Medellin, Antioquia, Colombia


Sigma Software Pte. Ltd. 20 Collyer Quay
#09-01 Singapore
Dubai, UAE

Sigma Software, Dubai Office
Bay Square Buildings, Unit 121, Level P, Building 7
Bay Square, Business Bay, Dubai, UAE, PO Box- 238605

+971 (0) 56 216 5922
Shoham, Israel

Sigma Software Inc.
Mitzpe 28, Shoham, Israel
Montréal, Canada

Sigma Software Group, Montréal office
25075 Rue Queen, Suite 1100, office 136, Montreal, Canada

Melbourne, Australia

Sigma Software, Australia Office
Level 1, 3 Wellington Street, St Kilda, Victoria 3182, Australia
Macclesfield, UK

Sigma Consulting Solutions Ltd.
The Ropewalks, Newton Street, Macclesfield, Cheshire SK11 6QJ, UK

+44 (1625) 427–718
Linz, Austria

SIgma Software
Kopernikusstrasse 22, EDV Consulting Bureau, Linz A-4020, Austria
Gothenburg, Sweden

Sigma Sweden Software AB
Lindholmspiren 9, Gothenburg 5 417 56, Sweden

+46 70 600 42 49
Stockholm, Sweden

Sigma Sweden Software AB
Hornsgatan 1, Stockholm 118 46, Sweden

+46 70 600 42 49
Los Angeles, USA

Sigma Software Inc.
410 N La Cienega, West Hollywood, CA 90048, USA

Bellevue, USA

Sigma Software Inc.
10400 NE 4th St., Suite 500, Bellevue, WA 98004, USA

New York, USA

Sigma Software Inc.
900 3rd Ave, 29th Floor, New York NY 10022, USA

San Jose, USA

Sigma Software Inc.
1484 Saratoga Ave, Saratoga, San Jose, CA 95070-3612, USA

Warsaw, Poland

Sigma Software, Warsaw Financial Center
Emilii Plater 53, floor 24, 00-113, Warsaw, Poland
Dnipro, Ukraine

Sigma Software, Dnipro Office
53 Sicheslavska Naberezhna Street, Dnipro 49000, Ukraine

+38 (093) 025 35 70
Sumy, Ukraine

Sigma Software, Sumy Office - Temporally relocated
13a Voskresenska Str., Sumy 40000, Ukraine

+38 (098) 210 01 64
Vinnytsia, Ukraine

600-Richchya Street 1, Vinnytsia, Vinnytsia Oblast, Ukraine, 21000

+38 (050) 782 47 67
Odesa, Ukraine

Sigma Software, South Office
7 Lekha Kachynskoho Str., BC Hitech Park Odessa 3rd floor, Odesa 65026, Ukraine

+380 (48) 737–5023
Lviv, Ukraine

Sigma Software, Lviv Office
7d Naukova Str., BC Optima Plaza 4th floor, Lviv, 79060, Ukraine

+380 (67) 742-06-29
Kyiv, Ukraine

Sigma Software, Kyiv Office
58 Yaroslavska Str., BC Astarta, 7th floor, Kyiv, Ukraine
Kharkiv, Ukraine

Sigma Software, Corporate Headquarters - Temporally relocated
Akademika Proskury St, 1, Kharkiv, Kharkivs'ka oblast, Ukraine, 61000

+38 (067) 510 62 08