Good ideas need a structure for realization. But these structures and processes should not end in themselves. Adaptation to the environment and the scope is key. Stakeholders and investors require a clear and transparent picture of the complex project dependences. Risks and their management need a clear definition. Sustainable Project Management uses tools from the well-recognized Critical Chain Project Management methodology to ensure a timely and successful completion of the project. Core areas are an intensive communication with all stakeholders, a transparent project plan, a clear scope, agreed success factors, and the empowerment of the project team.

Tikopia Consulting provides the expertise and skills to organize ideas into a robust project plan.

A project needs leadership and guidance during the execution. Regular reporting to the management and the sponsor are essential in controlling the progress. Sustainable Project Management gives the management an accurate and current status of the project. At the same time is allows the project team sufficient flexibility and resource management. The method allows a 90% on-time and on-budget completion, and still being 25% faster compared to more traditional methods.

Tikopia Consulting offers project leadership from planning to execution, from monitoring and reporting to the closing of developmental projects.

From regulatory and business perspective a thorough and reliable documentation is a key element. This documentation system should serve also communication, reference and collaboration purposes. Several systems are on the market that store information and allow sharing of information. Customized templates should help the team to document project related information.

Tikopia Consulting develops and establishes a suitable documentation system that meets the client’s requirements.

An effective Quality Management System is a legal requirement for the entire life cycle of a drug or medical device. It is designed to meet customer requirement, ensure a controlled manufacturing process and allows for continuous improvement. Well designed and well kept quality systems are balanced between requirements set by the authorities and applicability for daily routine.

Tikopia Consulting offers support in the implementation, maintenance and improvement of Quality Management Systems as described in ISO, ICH and cGMP guidelines.

Audits are a valuable tool to ensure compliance with regulatory requirements. In addition they are used to improve the companies own performance and to qualify suppliers.

Tikopia Consulting offers auditing in the area of GMP and supplier qualification.

European and national law requires batch release to the market by a qualified person, who is knowledgeable of production, quality control and registration.

Tikopia Consulting offers release service by a qualified person.

A project team runs through several stages of development. The team has always to deal with uncertainties and changes. Successful communications within the team and with the stakeholders are hallmarks of efficiency.

Tikopia Consulting offers trainings and teambuilding, together with coaching and supervision of project leaders.

International collaboration is an exciting opportunity for many companies. Care should be given to avoid common pitfalls and misunderstandings. Cross-cultural awareness is an important skill to develop. Different education, professional experience, cultural background, and language proficiency can make any collaboration a challenging endeavor.

Tikopia Consulting helps to understand cultural differences and can act as a “translator” to improve team efficiency and team spirit.

Professional use of communication tools in a virtual environment is equally important.

Tikopia Consulting develops a customized communication and collaboration strategy for virtual teams.

“Thought is not said, said is not heard, heard is not understood, understood is not agreed…” Resulting misunderstandings and delays are common themes in team meetings and discussions.

Tikopia Consulting helps to establish a reliable team, which builds on each other’s strength.

Knowledgeable and trained employees are an important asset for every company. A well-structured training program is essential and trainer have to be qualified and hands on.

Tikopia Consulting offers trainings in Project Management Methodology and Quality Management.

The preclinical program is a key element in drug development and thoroughly reviewed by the authorities. Safety aspects, the pharmacological profile and efficacy data from in-vitro and in-vivo studies are elements of this program.

Tikopia Consulting helps in the definition of the preclinical development plan.

Studies that will support the clinical phase are conducted at GLP certified sites and laboratories. The selection of a reliable CRO is a key element for success, as the safety program is usually developed in close collaboration. The timely completion of the studies is often on the critical path that leads to the First in Human studies.

Tikopia Consulting offers support in the selection and monitoring of CROs.

"Everything is poison, there is poison in everything. Only the dose makes a thing not a poison." Paracelsus (1493-1541), the father of toxicology, wrote this sentence long time ago. In our modern world this translates to the definition of median lethal dose (LD50), no observed adverse effect level (NOAEL), or the minimal anticipated biological effect level (MABEL). These are important parameters for the calculation of the starting dose in clinical studies and clinical risk-benefit assessments.

Tikopia Consulting performs toxicological assessments of drug candidates.

Sufficient funding is a recurring topic in start-up companies. The landscape of public and private financing is broad and difficult to oversee. It is a time-consuming process that distracts from the research or development scope. Preparing a company presentation that attracts potential investors is quite difficult, as many groups compete for attention. Translating scientific results into a language that is understood by non-experts is another challenge to overcome.

Tikopia Consulting offers support in identifying investors and presenting the company.

Selecting the right partner is critical for every company. The due diligence process is both critical and cumbersome. The review of available information, the gap analysis and subsequent valuation of the asset requires a lot of expertise, usually not found within one person. Getting the right people on board is a key to success.

Tikopia Consulting helps to organize a due diligence team and provides expert knowledge.

Quality by Design (QbD) is a scientific, risk based and holistic approach to pharmaceutical product development.

It is in the best interest of any pharmaceutical company to use QbD from the start of the product development all through the product life cycle to meet the expectations of costumers and authorities.

Authorities are increasingly looking for a thorough understanding of the product developed and produced. Starting with the Quality Target Product Profile the company defines the critical quality attributes of their product and subsequently a design space much wider than specifications and process parameters that have been used before.

Tikopia Consulting helps you on your way to a licensed product, from project management and risk analysis to quality management and control strategy.

Requirements for Medical Devices are becoming more demanding. Safety and performance of the device and the appropriate documentation will undergo a more stringent evaluation by the authorities.

 Tikopia Consulting performs biocompatibility assessments according to ISO 10993 and provides scientific support for the performance evaluation of IVDs.