Welcome to AlfaNordic A/S - Excellence in GMP

Project Management & Process

From single lines to entire plants

AlfaNordic’s Project management and Process consultants

During recent years, the pharmaceutical industry has been subject to a great number of changes in the market, with high expectations for growth and performance. The regulatory requirements are increasing and, at the same time, so are expectations for an even faster ”time to market” for new products. The equity must yield interest and must be invested in the right projects, and once the decision has been made, the project must be executed and managed, meeting timelines, economy and quality without surprises emerging during the process. Many companies have also established a framework course of events and a need for governance that the projects must follow in order to be exposed to a minimum of risk during the execution. Planning is crucial for the projects and is essential for making resources and internal staffing meet the project’s requirements.

This calls for skilled project managers who have gained experience from similar projects, possess strong tools to define scope, prepare budgets, plan and put the project out to tender and enter into contracts and not least perform risk management of the projects. In other cases, the projects need specialised discipline leaders or package owners, with emphasis on the technical discipline and GMP. Both management functions are based on the assumption that the right person with the right competencies is available and can be dedicated to the projects.

AlfaNordic Project management and Process consultants know the pharmaceutical industry’s challenges and help a number of the industry’s companies manage their projects from conceptual design to commissioned plant. In this way, the companies can get the right project and technical discipline leaders for a safe execution of the projects with focus on time schedule, economy and quality at the specified level. And they can, at the same time, minimise the use of internal resources.

We can help our customers by providing extremely skilled technical discipline competencies

Our project management competencies range widely within the pharmaceutical industry where knowledge of and experience with GMP are necessary. From raw material plants and utility systems over filling and packing lines to complete plants for vaccine and other products. We have at our disposal a number of extremely experienced project managers who have managed projects through all project phases and have facilitated cooperation processes with project teams made up of competencies across countries, skills and experience. We also have at our disposal technical discipline leaders with particularly strong technical disciplines within Automation, Process(chemistry), Process(mechanical) or HVAC and who have long experience as technical discipline leaders and are used to manage technical disciplines and teams.

  • Project Managers

  • Discipline Leaders

  • Client Representatives

  • Contract Administration

  • Package Owner

  • Contractor Management

We offer project managers, package owners and technical discipline leaders

We offer project managers, package owners and technical discipline leaders Project management of pharmaceutical or biotech projects from idea to finished plant, including owners representative and tendering services of engineering, turnkey, main or technical discipline contracts, and we can supply project managers who specialise in GMP and AB92 and FIDIC. As part of the project management or as a separate service, we provide competencies in the areas of programme planning, preparation of project planning, concept development, scope and interface management, tendering and procurement strategy including sourcing of consultants and contractors, overall budgeting, facilitation of team processes, analyses of partners and interested parties, risk assessments and reduction, plans for systematic maintenance, review of working environment and consulting services in connection with submission of applications to the authorities.

Technical discipline leaders who can either lead a small project and team because the project is especially technically heavy or as package owners where the technical discipline is part of a larger project. We have skilled technical discipline leaders within the areas of Electrical and Automation, HVAC, Utility or process packages including CIP/SIP and pharmaceutical water and steam systems.

Why us?

With AlfaNordic as a partner within project management and technical discipline leadership, your projects are one step closer to being completed on time, within budget and the agreed quality, with a minimum use of your own resources.

We are an entire department with project technical discipline leaders at AlfaNordic. We have many years of experience with international project management and technical discipline leading of GMP projects within the pharma and biotech industry. All with an inherent drive and wish to live up to our customers’ expectations. And all continuously undergoing further training within GMP projects, management and technical disciplinary skills.

Client Advantage

AlfaNordic’s project managers possess the competencies needed for the task and they have experience in being the customer representative and in handling contractors, consultants and authorities.

Vores Track Record

We have extensive experience with GMP projects – in Denmark as well internationally. We have performed projects for companies like Novozymes, Novo Nordisk, Bavarian Nordic, Pfizer, Leo Pharma.

Our sales and services process

The course of events for assignments normally goes through the following process.

1. Competency needs

The competency needs for the specified task are identified together with the customer. A sales meeting may be held. Please contact AlfaNordic sales department or an area manager.

2. Proposal and review

AlfaNordic draws up a proposal, identifies time frames and provides CVs for the task. The proposal is forwarded to the customer, followed by a review and a discussion. A meeting may be scheduled for further discussions of the proposal.

3. Contract

AlfaNordic sends the contract to the customer for approval. The contract covers economy, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic’s consultants start working on the task at the agreed date and time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and continuously hold status meetings with the customer as well as with the consultants.

6. Completion of task and customer evaluation

The task is completed within the agreed time and economy. AlfaNordic follows up with a customer evaluation form and a concluding dialogue with the customer.

Project Managers

Project managers from Managers to Directors. Independent management of projects.

Client Representatives

Builder advisors or builder representatives.

Contractor Management

Administration and management of contractors and consultants as the customer’s substitute.

Our customer evaluations

from previous tasks

Average customer evaluations for completed tasks. Grades applied according to a scale of 1 to 5:

  1. Unacceptable
  2. Less acceptable
  3. Acceptable
  4. Good
  5. Very good
GMP training in 2015
4.27
Projects in 2015
4.14
Risk Assessment in 2014
4.10

Contact our Management Consulting Team

Do you want to know more. Do you have competency inquiry or request. Or maybe you want to present us with a challenge? You are always welcome to contact one our area managers. They are ready to answer your questions.

Frank Winther-Hinge
Managing Director, AlfaNordic Academy

T: +45 5059 1598

Thomas Meldgaard Petersen
Co-owner, Board Member & Senior Consultant

T: +45 4050 9300

Preben Lind Hansen
Business Development

T: +45 6146 2340