Services

Our services (individually or combined) are offered in flexible arrangements (fee for service, fee per project, success fee, etc.) according to the nature of the task and your individual needs.


Marketing / Sales
• Pharma & Medicinal Technology
• Nano- & Microtechnology
• Renewable Resources
• Asia
• Cultural Awareness Training

Quality Assurance
• Quality Systems
• Audits
• ISO 9000
• LIMS

Technical Development
• Project Management
• Regulatory / Registration

Corporate Development /
Corporate Strategy

• Business Development
• Licensing / Partnering
• Alliances Management
• Portfolio Management
• Merger & Acquisitions
• Due Diligence



Marketing / Sales

Successful and efficient marketing needs to be planned in a tailor-made fashion according to the needs of the product and your company. This involves the preparation of a marketing plan in which all activities are balanced to the available budget to achieve optimal success. Tytonis Operations supports your organisation with:







Quality Assurance

On a global competitive market marketing, sales & sourcing depend on a functional quality system Regulations demand the set up of quality systems from early stages of development. The goal of quality assurance is to enable efficient internal and external communication as well as a functional supply chain.







Quality Systems

Setting up a working quality system can be time consuming and demand more staff than a young company may spare in the peak time of this process.

Being familiar with both start-ups and the needs of large organisations, Tytonis Operations can provide interim quality management to support your organisation. This function may cover internal as well as third party audits to fullfill regulations and support your sourcing – especially when importing goods from non-European regions.

Other services are: Risk assessment training and the implementation of FMEA data base systems.







Audits

Independent third party audits of European and Asian manufacturers support your sourcing and quality assurance departments.

Active ingredients for the production of medicinal products have to be manufactured according to the principles of good manufacturing practice. The licence holder has to verify this on site or use the service of an independent third party organization.

Tytonis Operations' audits are GMP regulatory conform. No economic relationship between audited company and its auditors may exist. Full language support is available due to own Chinese and Japanese speaking staff.







ISO 9000

Tytonis Operations supports you to become ISO certified to accelerate and promote your market entry. Based on your business requirements Tytonis Operations can support your organization in preparing documentation based on the structures already existing in your company. Carry out an internal audit to practice the certification audit. The Tytonis Operations team may join your company's staff at the time of the certification audit as well on recertification audits in the future.







LIMS

When moving to a larger production, the implementation of laboratory information software becomes both time and cost effective. We help you to select the system that matches your organisations needs.







Pharma

An important question in particular for smaller sized companies is: »How much quality regulations do I need to apply at which stage of development?«

Quality Assurance becomes relevant as soon as the project moves from the research activity towards development stage. In order to justify the application of a new product in patients, the underlying data must be in place following the quality/documentation requirements of the regulatory authorities.

Within our network team we have qualified persons and expertise to set-up and monitor the required quality requirements in your organization according to the requirements of your product development plan. Our key philosophy is »as much as needed at the right stage of development.«







Project Management

Every successful project depends on an experienced manager. In particular when time lines and budgets are tight the experienced project manager can react appropriately in case of unexpected event.

Most of the P@W members have such experience from different synergistic backgrounds and can advise you from the back office, but also can join as a member of your in-house team. We can assist you in setting-up the planning as well as to improve the efficacy of your intended development program in terms of development costs and time by coordinating and implementing the operational activities including supply chains.








Regulatory / Registration

Already at an early stage of development of a project, e.g. during the switch from preclinical to clinical phase, regulatory considerations become more and more important. Within the P@W team we have members with profound experience concerning communication and filings with the EMEA, FDA and also the Japanese and Korean regulatory agency. We strongly recommend that regulatory advice should be added early on in the development and business planning process in order to assess - among others - the right territorial filing strategy for your particular product and communicate timely with regulatory agencies together with an experienced person in the field. Moreover, this will allow for optimized budget/time planning of upcoming »go - no go« milestone events and the related assessments for your product portfolio strategy.








Corporate Development / Corporate Strategy

Corporate development is a necessary instrument to plan and develop the strategy of a company. Mostly, only larger size companies can afford to set aside professionals to form an independent Corporate Development and Strategy department. It should not be underestimated how important strategic planning is even for smaller size organizations. Every bakery shop owner will look around in his street whether there is already another shop that competes with him, before he makes such an investment. He will probably look around and assess the potential customer and their preferences. Will they primarily buy bread with small profit margins or do they prefer selected items such as cakes. Thus, without to much of thinking he is implementing forward-looking planning tools as also used in high-tech corporations to make the most optimal return on investment.

What sounds so simple and self-speaking is in high-tech corporations a very delicate exercise that can lead to painful decisions. Strategy is not only what you want to do, but also to determine what you are not doing! Choice-making is therefore an important requirement to obtain the highest possible gain from different available opportunities. To sustain corporate growth the choice-making process needs to be translated further down to your portfolio strategy, your budget, operational and marketing plans. An independent, external organization as Tytonis is able to do such corporate strategy planning and can guide you as part of your internal corporate team through this process.







Business Development

Business Development is implementing the corporate strategy into operational business. Here, the company gets exposed to the external world in order to communicate, interact and eventually corporate with e.g. other companies, universities, and other institutions. The business manager handles the deal-making process, including due diligence, contract negotiations (e.g. license, alliance, manufacturing, supply and other contractual arrangements), project-planning together with internal R&D functions, etc. Also financing, merger and acquisitions are important activities that belong to this category.

Tytonis and its independent network partners form a strong team that has done this work for many years in different successful companies. We have also the right networks both on the (bio)pharma business and R&D side in place, which is an extremely important factor to liaise successfully with a selected partner.







Licensing / Partnering

Licensing is one of many ways to get ownership to a technology or product by acquiring the part of the intellectual property for which the licensor has obtained an exclusive market position. Usually, this concerns a family of patents. A license is in other words nothing else than a merchandise based on IP matters.

Although, the term »license« is very popular among business executives, there are also other ways that can be attractive in order to participate in the technology or product of another partner. One is to form a risk/benefit sharing alliance in which both parties keep contributing actively to the success of a product. This makes usually sense when two companies have heterogeneous expertise and capabilities that may be needed to develop a successful commercial product. In particular, when two small or midsize companies come together each individual company can focus on its specific expertise and does not need to develop the same skills of the partner company.

Tytonis together with its independent partners can do all the related steps in licensing, including the value assessment, term sheet and license agreement negotiation, freedom-to-operate analysis, etc. The Tytonis team members are real deal-makers and can use all their creativity to respond adequately to the counter party to make a win-win deal happen.







Alliances Management

Once an alliance/joint venture deal has been closed the real work actually starts. Often your partner you are cooperating with has a very different company culture and way of working. This is often not visible during the deal negotiation process since the involved business executives work from a different background than the researchers that have to cooperate on a daily operational level. In this respect some members of the Tytonis network can guide you through different cooperation and communication tools so that the alliance/joint venture remains intact even in difficult situations.







Portfolio Management

Portfolio Management is the most crucial part to achieve with the most predictable degree of certainty your commercial success. What does portfolio management embrace? Essentially, the portfolio analysis leads to a ranking of projects into priority categories. This is a team effort, which should be done with different experts involved. The evaluation process includes the assessment of the medical need, commercial value and development/financial risk. Based on the ranking projects will be planned according to monitoring requirements. Development milestones are defined and the specifications that needs to be achieved to continue the project to the next phase. At the end the combination of projects in the portfolio shall result in a sufficiently high-cumulated probability value. In this case a non-successful project can be timely replaced with a back-up without risking the overall success probability of the company.

Tytonis has members that have the experience to perform such analysis. However, it is often a team effort that involves also the in-house expertise of our partner. We can guide you through this evaluation process so that you get the experience how to react timely to certain threads and unexpected outcomes.







Merger & Acquisitions

Merger & Acquisitions (M&A) often have a crucial impact of both company's organizations. Beside the access to technologies of another company, the human assets play an important role. Often companies have different cultures, especially when a smaller company is acquired by a larger one. The human work-force is a crucial part of the intangible assets which bears the know-how and experience that is only properly documented in the individual brains.

Tytonis has experience beyond the deal-making that can help to provide some advice how the human side can be taken optimal care of. In case of cultural changes we have ourselves external experts that can assist in the set-up of a change-management plan.







Due Diligence

Due Diligence is the evaluation process to assess the current value of a particular product, technology or even a whole business/company. Tytonis and its network partners is capable to conduct the entire evaluation involving the