Welcome to AlfaNordic A/S - Excellence in GMP

Management Consulting

From idea to implementation

AlfaNordic’s Management Consultants

During recent years, the pharma and biotech industry has been confronted with changing market conditions. The demand is dominated by a swiftly changing legislation, an increasing number of rules and tightened requirements by controlling authorities as well as an increasing price pressure from authorities and consumers. The supply of medicinal products is also challenged by constant changes: Globalisation of the entire value-added chain, a growing tendency to outsourcing of the production to less salary-heavy countries, new competitors and sales channels, and the expiry of important blockbuster patents. These conditions put added pressure on the production, and old industry structures are challenged at the same time. Businesses must be willing to change in order to survive.

We can help from idea to implementation

We offer broad knowledge within strategic and organisational consulting services ranging from Risk Assessments in the industry to the administration, GAP quality analyses, interim management and Guidelines for procurement – from idea to implementation.

  • QRM Risk Assessment – ICHQ9

  • GMP/GDP GAP analyses

  • Management Consulting

  • Procurement Compliance

  • FMEA (Failure Mode and Effects Analysis)

  • Training

  • Interim Management

  • Strategy & Business Management

We specialise in

customised solutions

AlfaNordic Management Consulting knows the challenges that the pharmaceutical industry is facing at the moment. We help companies that operate in this industry gain awareness of changes so that the changes can be addressed to their advantage. With pharma and biotech as our focus industry, we specialise in offering customised solutions – from strategic concepts to the implemented results.

Our approach to quality assurance of the process in the production or administration builds on a ”going backwards” strategy. We work going backwards in the process thus making it possible to identify the potential improvement suggestions in a way that is a lot more focused than the final quality requirements (output). The reverse, that is, starting from the beginning, requires a much higher prediction of how the individual process step will react to any sources of error in relation to each other and in the end in relation to the final output.

Please contact us to hear more about why we believe that the process labyrinth must be the starting point in order to find the fastest and shortest way out.

Why us?

We are a specialised consulting department under AlfaNordic providing services to the pharmaceutical and biotechnological industry. We feel that we are fully equipped to compete with companies many times our size for the following reasons:

  • We combine solid management consulting competencies with in-depth pharmaceutical and biotechnological expertise, developed during many years of service to the industry.
  • We hire skilled and knowledge-driven people who know how to keep several balls in the air at the same time. Quality, speed and execution are key words for ensuring effective work routines, regardless of whether the role is as a participant in interdisciplinary teams or as an advisor to top management.
  • We promote professional and personal development and strive to make talented people even better.

Controlled growth and increasing efficiency are often key words for a company’s success and profitability. These goals are just as often the company’s highest priorities, but can be reduced or disappear via daily interruptions by inadequate and risky processes in the administration and the production. As a partner, AlfaNordic will be the best within this field. We assess the strategic risk and provide organisational consulting services to the entire value chain in your company.

Client Advantage

Our employees all possess significant knowledge and experience within the pharmaceutical or biotechnological industry – both from the part of the customer and as consultants. Our consultants are all able to enter into a close cooperation with our customers as if they were part of the team in the company. This is true regardless of whether the assignment is for a short or longer period of time and whether it is in Denmark or abroad. As a consulting house we take an active part in spotting new trends in the industry and thus breaking down barriers and developing and creating sustainable solutions for our customers.

Our Track Record

Our consultants have performed risk management for some of the biggest companies in Denmark. Our projects within the consulting field have brought us to Asia, South and North America and to several countries in Europe. Customers like Bavarian Nordic, Novo Nordisk, Leo Pharma, Statens Serum Institut and Riemann Skin Care are just some of the companies that our consultants visit. We hope that we can also pay you a visit.

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.

QRM Risk Assessment – ICHQ9

Risk management is a systematic process for assessment, control, communication and review of risks in relation to the quality of medicinal products. We use it proactively in collaboration with our customers. We hold workshops where we discuss and review critical processes, clarify problems and present suggestions for possible solutions.

Training

We deliver training and education programmes within QRM Risk Assessment according to ICHQ9.

FMEA (Failure Mode and Effects Analysis)

Interest in FMEA is growing. The model was developed for the military back in 1949 and was used in earnest when NASA started working with risk assessments in connection with their space programme. FMEA models are useful for creating a structure and for identifying the most alarming risks and areas that require measures to prevent a problem from occurring in the first place. The idea is to analyse potential failures and errors. These risks are systematised to illustrate the effect and probability of errors.

Management Consulting

Our company consulting services focus on your most critical issues and possibilities: strategy, organisation, business, transformation and due diligence, across all industries and geographical areas.

GMP / GDP GAP Analysis

Audits constitute a crucial part of GMP / GDP ensuring compliance with current GMP/GDP requirements and crucial for maintaining a ”license to operate” in the pharmaceutical and biotechnological industry. We conduct GAP analyses based on the current state of daily routines, operation and applicable requirements.

Interim Management

Interim Management is a flexible and value-adding management tool and often a good solution to the management needs arising in an increasingly dynamic world. Our interim managers carry solid management experience in the baggage and typically solve tasks within top management, strategic management and project or operation management.

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

Christian Ilsøe
Co-owner, Board Member & Senior Consultant

T: +45 5152 9030

Henrik Linnemann
Co-owner, Board Member & Senior Consultant

T: +45 2811 0091

Preben Lind Hansen
Business Development

T: +45 6146 2340