GMP • GxP • Regulatory Affairs

Bringing production into GMP compliance — predictably, on time, without overspending

A team of experts with years of hands-on experience. We don't just prepare you for inspection — we build a quality system that works for you.

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200+
successful projects
98%
pass inspection first time
10+
years of experience

GMP requirements tighten every year

What took 3 months to prepare in 2020 now takes 8-14 months. The cost of a mistake — production suspension.

Roszdravnadzor conducts thousands of inspections every year
72% of rejections are due to insufficient documentation
Average GMP violation fine — from 500,000 to 5,000,000 RUB
Production suspension costs from 200,000 RUB per day

Results that speak for themselves

Every project delivers concrete numbers, not promises.

Solid dosage forms
Pharmaceutical Manufacturing
Production suspension due to validation system violations
Production restored in 45 days. Passed Roszdravnadzor inspection with zero findings.
45 days
to production restoration
0 findings
at inspection
Dairy products
Food Production Facility
GOST R ISO 22000 certification and HACCP audit preparation required
Full certification in 6 months. 30% budget savings through process optimization.
6 months
from request to certificate
-30%
off compliance budget
Implantable medical devices
Medical Device Manufacturer
Greenfield Roszdravnadzor inspection preparation for new production facility
Full documentation from scratch. Inspection passed first time.
8 months
from zero to inspection
100%
first-time pass rate

How we help

Three core areas that cover any enterprise's GMP compliance needs.

Diagnostics & Audit

Comprehensive assessment of current production and quality system state. We identify gaps, prioritize by criticality, and build an elimination roadmap.

  • GMP/GxP audit of any complexity
  • Documentation and SOP review
  • Infrastructure and process analysis
  • Prioritized roadmap

Validation & Qualification

Development and execution of validation protocols. IQ/OQ/PQ for equipment, process validation, cleaning, analytical methods.

  • Process validation
  • IQ/OQ/PQ equipment qualification
  • Analytical method validation
  • Cleaning validation (CIP/COP)

Documentation & Support

Development of complete GMP documentation sets and ongoing support: from SOPs to technical files and registration dossiers.

  • SOPs, instructions, regulations
  • Technical files
  • Roszdravnadzor registration
  • Subscription support

Methodology

A proven methodology refined over years of practice. At every stage — clear deliverables and transparent timelines.

01

Risk Assessment

Identify critical gaps. Assess scope and priorities. Deliver a report with specifics: what, in what order, at what cost.

1-2 weeks
02

Design

Develop quality system architecture. Determine gaps between current and target state. Fix budget and timeline.

2-3 weeks
03

Documentation

Create the required document set: SOPs, validation protocols, instructions, record forms. Every document undergoes internal review.

2-4 months
04

Implementation & Training

Deploy documentation in production. Train staff. Run pilot launches. Validate effectiveness in practice.

1-3 months
05

Support & Monitoring

Assist during inspections. Maintain documentation relevance. Implement CAPA from audit results. Update when requirements change.

Ongoing

Industries

Each industry has specific GMP requirements. We know that specificity.

Pharmaceuticals

GMP, GLP, validation, registration

Food Production

HACCP, ISO 22000, TR CU

Medical Devices

ISO 13485, Roszdravnadzor

Biotechnology

GMP for biologics

Cosmetics

GMP for cosmetic products

Dietary Supplements

TR CU, HACCP, GMP

Team

Experts with real production floor experience. We don't theorize — we know how it works from the inside.

AP

Alexey Petrov

Managing Director, GMP Consultant

Over 10 years in pharmaceutical manufacturing. Former Head of Quality. Successfully conducted dozens of Roszdravnadzor inspections.

MK

Maria Kozlova

Head of Validation

Over 10 years in validation. Expert in IQ/OQ/PQ, process and analytical method validation. Experience with international regulators.

DS

Dmitry Sokolov

Head of Documentation

Over 8 years in GMP documentation. Expert in SOPs, technical files, and registration dossiers.

Ready to discuss your project?

Describe the task — we'll prepare a preliminary assessment within 2 business days. Free and without obligation.

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Questions & Answers

A standard small production audit takes 5-7 business days. A comprehensive pharmaceutical enterprise audit takes 2-4 weeks. Timeline depends on the number of production areas and process complexity. After the audit, you receive a detailed report with an elimination plan.
Cost is calculated individually after free diagnostics. Typical range — from 500,000 to 5,000,000 RUB depending on production scale and current documentation state. We fix the budget before starting — no hidden charges.
Yes. We guarantee: if inspection is not passed due to our reasons — we eliminate findings and conduct re-preparation free of charge. Our first-time pass rate is consistently high.
Yes. We adapt our approach to scale. For small enterprises, we offer package solutions with fixed pricing. Minimum project — small area audit in 2 weeks.
For diagnostics, we need access to production facilities and current documentation (if available): technical passports, instructions, logs. We provide the complete list after the initial consultation.

Request a Project Assessment

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