Solutions.
Project Consulting.
Take advantage of our expertise to make your projects in medical technology, pharmaceuticals, IVD and biotech a success.
Complex?
Time-critical?
Regulated?
Let us lead your project to success!
Project Consulting - The experts for your project success.
Our project consultants have in-depth expertise and many years of experience in regulated sectors such as pharmaceuticals, medical technology, IVD and biotech. They take responsibility for ensuring that your projects run efficiently and successfully, even when internal resources are lacking.
When it comes to time-critical projects, we ensure that you meet deadlines while achieving high-quality results. We put together dynamic teams that work closely with you and respond to your specific requirements.
With our extensive expertise in compliance and regulatory requirements, we ensure that your projects meet the highest standards. Our aim is to offer you tailor-made solutions that meet your requirements and overcome the regulatory hurdles.
Project Consulting - Your projects, our joint success.
Our project consulting services are specially tailored to the needs of companies in regulated industries.
Targeted expertise.
- Access to highly qualified specialists: Direct access to highly qualified specialists with extensive experience in the pharmaceutical, medical technology and IVD sectors.
- Efficient strategy development: Development of strategies to ensure that your projects comply with regulatory requirements.
- Broad network of specialists: Access to a broad network of experts to help you tackle complex project requirements.
Adaptive strategies.
- Tailor-made team composition: Tailor-made team composition that is perfectly tailored to your specific project requirements.
- Dynamic solutions: Dynamic solution approaches in order to be able to react flexibly to changes in the course of the project.
- Agile processes: Using agile methods to increase efficiency and achieve your project goals faster.
Reliable partnership.
- Seamless project management: Seamless project management that ensures smooth and timely project implementation.
- Transparent communication: Transparent communication with regular updates and clear reports so that you always have an overview.
- Long-term strategies: Long-term strategies that create sustainable added value and support the growth of your company.
How our Project Consulting solves your challenges.
Challenge.
An international pharmaceutical company was faced with the problem of converting its cleanroom from class A to class D. Due to a lack of internal resources, the company was unable to complete the project without external support. In addition, strict regulatory requirements in the areas of HVAC and sterile production had to be met.Measures.
- Entourage provided an experienced project manager within 8 weeks.
- The project manager was responsible for both project and construction management.
- Responsibility for compliance with ISO standards and pharmaceutical compliance.
- Coordination of the trades involved and ensuring timely implementation.
Results.
- The project was completed on schedule.
- Internal permanent employees did not have to be involved.
- All regulatory requirements were met in full.
Success.
Entourage enabled the client to successfully complete the complex project without burdening internal resources. In addition, risks in connection with social security claims were avoided.Challenge.
An international contract manufacturer was under great time pressure to fill the position of production manager on an interim basis. A freelance solution was not possible due to regulatory and internal requirements.Measures.
- Provision of an experienced pharmacist within two weeks.
- Immediate integration of the consultant into the operational processes.
- Option to take on the consultant on a long-term basis to ensure a sustainable solution.
Results.
- Seamless continuation of the production line without production interruptions.
- Stable solution without the risks of bogus self-employment.
- Flexibility for the client through the possibility of a permanent position at a later date.
Success.
Entourage helped the client to maintain the production process without delays and meet the tight deadlines. The solution also offered a long-term option to take on the consultant.Challenge.
A leading global biotech company needed new dossiers for the global approval of its IVD products in accordance with the requirements of the IVDR. There was a lack of internal resources and expertise for the regulatory requirements.Measures.
- Provision of an experienced consultant within a few weeks.
- Carrying out the classification of IVD products.
- Creation of a gap analysis to identify the necessary measures.
- Coordination of dossier preparation and timely submission of documents.
Results.
- Successful and timely preparation of dossiers.
- Compliance with all regulatory requirements without overburdening internal resources.
- Flexibility by not employing a permanent consultant.
Success.
Entourage supported the client in meeting regulatory requirements on time and accelerating market access. This enabled the company to act faster on the global market and minimize compliance risks.Start your next project with us!
Project Consulting. Our offer.
The three types of employment.
Definition.
Project-related provision of permanently employed life science experts from Entourage for specific tasks or projects at the customer's premises.
Description.
This type of contract is particularly suitable for long-term projects that do not require permanent employment by the client. Entourage experts work closely with the client's internal teams without being delegated authority. The focus is on project-related service provision, with Entourage assuming full responsibility for implementation, while the client benefits from the flexibility and specific expertise of the external consultants.
Pros.
Flexibility in project duration: The duration of the assignment can be adapted to the project requirements, without long-term personnel obligations.
No risk of bogus self-employment: As Entourage's employees are permanent staff, there are no legal risks in relation to bogus self-employment.
High level of expertise: The experts regularly work on comparable projects and therefore contribute sound, industry-specific knowledge.
Definition.
Hiring highly qualified specialists (e.g. scientists, engineers) for operational tasks directly from the customer, who is given authority over the employees.
Description.
This is a short-term to medium-term assignment of experts who are integrated into the client's daily business. The client has direct authority over the experts, while Entourage takes care of all administrative tasks such as salary payments and social security contributions. This form of employment is ideal if the client needs to bridge short-term staff shortages or requires specialized experts for operational tasks.
Pros.
Rapid availability: The experts are available at short notice and can be integrated into existing processes immediately.
Low risk of bogus self-employment: As the employees are subject to the client's authority to issue instructions, there is no risk of bogus self-employment.
Option to take over: The client has the option of taking on the leased employees as permanent employees in the long term if this proves to be advantageous.
Definition: A project assignment in which permanent Entourage experts assume responsibility for the fulfillment of clearly defined project goals. The work is remunerated on the basis of defined milestones.
Description: The contract for work is ideal for projects where the objective and the results to be achieved can be precisely defined in advance. Entourage assumes full responsibility for the execution and success of the project. Remuneration is based on clear, pre-defined milestones, which enables a predictable and transparent cost structure for the customer. As no authority is transferred to the client, Entourage's experts remain responsible for achieving the project goals.
Pros.
Focus on results: Clear definition of project goals and results, ensuring that work is targeted and efficient.
Predictable cost structures: Billing is based on milestones, which enables the customer to clearly calculate and control costs.
No authority to issue instructions: The customer does not transfer any authority to issue instructions, which means that Entourage retains overall project management and the customer can rely on the results being delivered.
Maximize the success of your project!
The advantages of Project Consulting for your company.
Compared to permanent employment.
- No headcount
- On-site or remote use
- Flexible project runtimes
- Possible takeover
- Resources available in the short term
- Lack of expertise
- Quality through permanent employees
Versus Freelancing.
- Quality through permanent employees
- Delegation of authority
- Disciplinary enforcement
- Combination of conception and operation
- Professional interdisciplinary teams
- Low fluctuation
- Lower hourly rates
Your path to project success with Entourages Project Consulting.
At Entourage, we support you with customized project consulting expertise to achieve and exceed your goals in the pharmaceutical, biotech, medical device and IVD industries.
- Professional initial consultation to understand the specific requirements of your project.
- Definition of strategic goals and delimitation of the project scope.
- Planning and coordination of the next steps with our team of experts.
- Detailed assessment of your project requirements by a team of experts.
- Development of a project roadmap that integrates strategic goals and operational steps.
- Definition of a clear project vision, aligned with your business objectives.
- Putting together the ideal project consulting team for your project.
- Initiation of project work with a clear focus on efficiency and target orientation.
- Implementation of advanced solutions and methods to ensure sustainable success.