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 a wide range of knowledge in strategic and organizational consulting services from risk assessment in industry to administration, GAP analysis, interim management and procurement guidelines - from idea to implementation.

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.

The following is an example of the expertise we have in Management Consulting:

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.

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.

Courses and training

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

Why us?

We are a specialized consulting department within AlfaNordic, serving the pharmaceutical and biotechnology industry. We feel able to compete with companies with much bigger size for the following reasons:

Controlled growth and increasing efficiency are often the key to a company's success and profitability. These goals are just as often the company's main priorities, but can be reduced or disappear by daily disruptions of inadequate and risky processes in administration and production. As a partner, AlfaNordic will be the best within the field. We evaluate the strategic risk and provide organisational advice to the entire value chain of your company.

Our sales and delivery process

1. Competency needs

The competence requirement for the desired task is described together with the customer. Possibly a sales meeting will be held. Contact AlfaNordic Sales or a Function Manager.

2. Proposal and review

AlfaNordic prepares presentations, time requirements and CVs for the task, as well as sends the presentation to the customer and goes through it. A possible meeting for further discussion of the presentation.

3. Contract

AlfaNordic submits a contract for approval by the customer. The contract includes financial information, named consultants and time consumption, as well as start and end dates.

4. Start of task

AlfaNordic's consultants start the task at the agreed time.

5. Continuous follow-up

AlfaNordic follows up on the consultants and holds regular status meetings with both the client and the consultants.

6. Completion of task and customer evalution

The task ends at the agreed time and with the agreed price. AlfaNordic follows up with a customer evaluation form and a final dialogue with the customer.

Contact our Management Consulting team

Frank Winther-Hinge
Forretningschef / Vice President
+45 5059 1598
Rasmus Kriegel
Market Director
+45 3144 7515

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