BIOTECH PHARMA


GMP VALIDERINGER & PROJEKTLEDELSE

Services

Project

EXCELLENCE

We have extensive experience with project management of pharma and biotech projects. High success rate of completion on time within the budget securing the right quality. User representatives in preparation of investment projects using the stage-gate model.

GMP & Engineering

PROFESSIONALS

Our trained GMP validation specialists are highly educated engineers with substantial knowledge of pharma and biotech production equipment, utilities, automation and processes and the required documentation.

Validation

DQ | IQ | OQ | PQ | PPQ | EMPQ

We have hands on experience with preparation of all validation documents from the design phase to completion of the project, test and qualification of pharma and biotech production equipment, classified facilities and utility systems and validation of processes.

Documentation

VPL | VMP | URS | SOP | FMECA | NC

We have solid experience and are highly competent in preparation of all kind of GMP documents within, nonconformity handling, risk assessments, validation and maintaining the validated state. FDA and EMEA inspection support.

Pharmaceutical Production Projects

We can manage and execute the entire project, part of it or provide validation specialist assistance

GA2 are specialized in project management and validation for biotechnology and pharmaceutical clients. We can manage and execute the whole project, part of it or provide validation specialist assistance.

We have extensive experience executing both small and large projects within rebuilding, changes and GMP qualification of pharma and biotech equipment, utility and classified facilities.

GA2 consultants are engineers with long experience and in-depth validation knowledge of production equipment, utilities, and facilities.

We work as user representatives in projects as project managers, package owners, and specialists or assist a project team with specialist knowledge where parts of the project are carried out by us.

We have a high success rate in the completion of projects on time, within budget, and qua our specialist knowledge and hands-on experience with pharma and biotech, we can provide clients the right solution at the right quality level. We have a large network and experience in collaboration with other specialists and other contractors as we know from other projects.

For GA2 success of the client is paramount. We are well aware that time and money are essential in a competitive market.

We do our utmost to provide the service the clients request and need – no more no less – and to deliver in close collaboration with management, employees and other external service providers.

For us, it is crucial to secure the right GMP level and successful execution of your project right first time on time.

Successfully Finished Projects

Examples & Cases

Project Plan Gantt Diagram

Project

Management & Execution

  • Implementation and qualification of virtualized Process Control System (PCS)
  • Change and qualification of PCS/automation applications (HPLC, CIP and Process systems)
  • Rebuilding and qualification of classified pharma facilities
  • Rebuilding of airlocks; qualification of HVAC, FFU, EM
  • Projects within changes and qualification of pharma production equipment, and utilities
  • Implementation and qualification of decanter, capture column, and frame filter
  • Development of risk assessment system
  • Implementation of equipment for Single use Bioreactor
  • Establishment of QC sample laboratorium
Watch Pointing to the Word Compliance

Completed validations

| DQ | IQ | OQ | PQ |

  • Changes and qualification of mixing systems
  • Qualification of automated bioprocess control system and column
  • Change and qualification of clean utility systems (CS, WFI, N2)
  • Change and qualification of CIP system
  • Change and qualification of utensil washer
  • Change and qualification of bioprocess systems
  • Purchase and qualification of production tanks
  • Purchase and qualification of scales
  • Qualification of GLP equipment 
  •  
Risk Management

Other services        

Provided                                  

  • Change Requests
  • Validation Plan (VPL) & Validation Master Plan (VMP)
  • Risk Assessments
  • User Requirement Specification (URS)
  • Design documents
  • Test plans, test references, validation protocols/reports
  • SOP preparation
  • Nonconformities
  • Audit Support
  • General GMP Consultantcy
  • Interim Management

About us & Location

Medicon Valley

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ABOUT US

GA2 Consulting are specialized in pharma and biotech. We are engineers with long experience and in-depth validation knowledge of production equipment, utilities and facilities. The company is owned by Ph.D Bettina Christiansen. She has experience great success with vital projects for big pharma. Prior to her consultancy work, she has been head of production, worked as manager of research coordination as well as being a scientist herself. This combination has prepared her for the successfull work conducted at pilot plants bridging the gap between R&D and production. To learn more please click the link below for her linkedin profile, and please do not hesitate to call or write us to know more about how we may assist you and your company.

Linked in
Map Location Denmark Medicon Valley (Københavnsområdet og Skåne i Sverige)
LOCATION MEDICON VALLEY

Being located in Kongens Lyngby north of Copenhagen we are right in the center of Medicon Valley, one of Europe's strongest life science clusters. The cluster is spanning over greater Copenhagen and southern Sweden. We are within driving distance of the entire cluster and the many production sites of Zealand. From Vejle in Jutland we are in driving distance from Fyn and a large part of the industrial area of Jutland. Closely located to international airports we're able to service the rest of Europe. Please do not hesitate to call us or write us to know more and find out if we can help you.

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