Smart
solutions for pharmaceuticals

0
years in Russia
0
years in EU

01

Engineering

02

Constructing

03

Consulting

04

Training

ENGINEERING

We specialize in creating engineering projects in the following areas:

Pharmaceutical production

Biotechnology

Chemical
production

Medical
products

Food
additives

Cosmetics

  • Development of technical specifications
  • Development of conceptual projects
  • Development of project documentation for all stages
  • Development of URS for technological equipment
  • Supply of technological equipment
  • Partial deliveries of equipment and systems
  • Installation and launch of technological systems and equipment
  • Construction coordination and management

Our experienced team will organize all the necessary work and bring it to successful validation results.

  • Robotic systems
  • Complete technological systems and lines
  • Piping systems
  • Other technologies:
    • sterilization systems
    • insulators and glove boxes
    • washing equipment
    • solution preparation systems
    • process filters,pressurized/atmospheric reactors
    • CIP/SIP systems
    • serialization equipment
    • clean room furniture
  • Clean rooms
  • Engineering systems, HVAC
  • Low-current system
  • Auxiliary systems
  • Basic engineering equipment
  • Engineering systems
  • Purified water (PW)
  • Water for injection (WFI)
  • Pure steam (PS)
  • Medical gases
  • Compressed air
  • Vacuum
  • Heating and cooling systems
  • Industrial steam and condensate drain
  • Storage and logistics systems

Constructing

A-Z construction of objects

  • General supply services
  • Construction supervision services (author’s and technical supervision)
  • A-Z creating objects
  • Certain types of construction and installation works as a contractor
  • Installation and launch of technological equipment
  • Work coordination and consulting

Consulting

Special types of consultations

  • Audits of the quality assurance and control system
  • Audits of the production documentation system
  • Implementation and modification audits of the quality assurance system
  • Analysis of project documentation (DQ, DR, EDR)
  • Consulting support for a new and/or reconstructed facility

 

Risk Analysis in Pharmaceutical Manufacturing

  • Architechtural solution for individual technological processes
  • Architechtural solution engineering systems
  • Architechtural solution for complete lines and sections
  • Development of the CAPA system

Training

Seminars

Our team conducts one-day consulting seminars

  • Expert GMP Issues
  • GMP news
  • Hot topics for discussion in GMP

Corporate seminars

Depending on your needs, we can train the company’s personnel on the following topics:

  • Good Manufacturing Practices
  • Good Distribution Practice
  • Production of API and FPP
  • Aseptic and sterile production
  • Sterilization processes
  • Clean
  • Premises
  • Clean media systems
  • Qualification and validation
  • Validation of computerized systems
  • Data integrity, electronic document management
  • Serialization, validation and transfer of analytical methods
  • Pharmaceutical microbiology
  • Materials for pharmaceutical production
  • Quality assurance system in pharmaceutical production
  • Risk analysis
  • GMP audits

Seminars can be held at your enterprise or on our territory in the Russian Federation

Contact us to receive an individual program

Clients

INFAMED K
F-sintez
кфф
bio_logo_ru

Contact us

Address

Moscow
st. Dolgorukovskaya
34/2

Message us

Use the form below to contact us if you have any questions.
We will be glad to provide you an individual consultation!

Partners

GMProject s.r.o.

Janská 4
746 01 Opava CZ

www.gmproject.cz

ETC "Conven"

Clean rooms
Engineering systems

www.etc-conven.ru