GMP • GxP • Regulatory Affairs

GMP compliance for pharmaceutical, food and medical device manufacturing — calm, planned, predictable

We help companies prepare for inspections and maintain their quality systems: audits, validation, documentation. We start with a diagnostic visit and build a plan with clear deadlines.

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12+
years of team experience
40+
projects supported
6
industries

Requirements are tightening, preparation takes longer

Inspectors pay ever more attention to the quality system and documentation. The cost of a mistake — findings, sometimes a production halt.

Regulatory requirements change — documents must be updated in time
A common cause of findings — missing procedures and records
Violations carry fines up to suspension of activity
Every day of forced downtime costs money

Typical engagements

Three examples typical for their industries. Companies are not disclosed.

Solid dosage forms
Pharmaceutical Manufacturing
A scheduled inspection raised validation findings; a follow-up check was coming
Put validation procedures back in order and prepared the site for the follow-up check — accompanied the inspection on site.
3–4 months
from audit to readiness
No critical
findings at the follow-up check
Dairy products
Food Production Facility
Retail chains required ISO 22000 and HACCP certification
Built the food safety system and documentation, prepared the plant for the certification audit and passed it.
5–6 months
system preparation
ISO 22000
certificate obtained
New medical device production
Medical Devices
Registration required a QMS document set developed from scratch
Developed the documentation, helped set up the processes and supported the registration procedures.
6–8 months
documentation development
Registered
registration certificate obtained

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

A small team of specialists who came from production floors and quality departments.

Lead Consultant, GMP

12+ years in pharmaceutical manufacturing: worked in a quality department, accompanies inspections.

Validation Specialist

IQ/OQ/PQ, process and analytical method validation; works with equipment vendors and laboratories.

Documentation Specialist

SOPs, technical files, registration dossiers; keeps the document system up to date.

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.
The outcome of an inspection depends on the regulator's decision, so we do not promise results. But if findings arise from our documentation, we fix them at our expense and accompany the follow-up check.
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 agree on the required list after the initial consultation.

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Describe your task. We'll respond within 2 business days with a preliminary timeline and budget estimate.

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