Areas of Expertise

CMC is the basis for every new medical entity on its way to the market. Our expertise covers all challenges which customers may encounter with their compound during development and later on the market.

CONELIS Experts offer Consultancy and Support for:

• API synthesis, Formulation development and QC-analytics
• Process development and manufacturing for Biologicals
• Due diligences and other project evaluations
• CMC development and manufacturing strategy incl. life-cycle management and contract manufacturing
• Submissions to authorities
• Interdisciplinary workflows to ensure appropriate communication and documentation for life-cycle management

Each project has its specific CMC aspects due to the different nature of compounds. We tailor our consultant work to your individual needs to safeguard the selection and development of most promising candidates and formulations in a successful, time and cost efficient manner.

Contact person: Michael Hildebrand

Topics:

The experts are:

Anke Maaßen

Expert for In Vitro Diagnostics (IVDs)

• Regulatory Affairs (EU regulations: IVDD and IVDR)
• Quality Management and Assurance
• Internal and Supplier Audits
• Support for Manufacturing and Control

Michael Hildebrand

Expert for CMC, Biopharmaceuticals and QP topics

• CMC support from research to life cycle management
• Formulation development and Quality Control
• GMP and Qualified Person support

Heiner Zindel

Expert for Biotech Process Development and Manufacturing

• Business Development and Support for CMO/CRO’s
• Process Development (USP and emphasis on DSP)
• Qualifications / Validations (DQ, IQ, OQ, PQ based on an FMEA approach)

Siglinde Dürr

Expert for Quality Assurance

• Implementation of Quality Systems according to GMP, GCP or ISO regulations
• Conduct quality audits (GMP/GCP/ISO)
• Develop and implement Standard Operating Procedures
• Project management of funded projects

CONELIS Experts offer Consultancy and Support for:

• Design and management of non-clinical drug development programs according to current scientific and regulatory standards
• Disease-specific target identification, validation and drug candidate evaluation of data for strategic decisions
• Studies in relevant disease models (primary pharmacodynamics)
• General pharmacology studies, receptor and enzyme screens (secondary pharmacodynamics)
• ADME (absorption, distribution, metabolism, excretion) and drug-drug interaction studies
• Non-clinical safety studies (safety pharmacology, investigative and regulatory toxicology)
• Writing and review of scientific and regulatory documents
• Grant application and management of funded projects

Contact person: Jens Hoffmann

Topics:

The experts are:

Frank S. Zollmann

Expert for Pre-/ Clinical Drug Development

• Safety pharmacology, toxicology, pharmacogenomics
• Integrated preclinical & clinical development up to PoC
• Clinical pharmacology

Hans Hendriks

Expert for Pre- and Early Clinical Drug Development

• Scientific and Regulatory Medical Writing (Oncology, Inflammatory Diseases)
• Non-Clinical and Early Clinical Anticancer Drug Development

Michael Hildebrand

Expert for CMC, Biopharmaceuticals and QP topics

• CMC support from research to life cycle management
• Formulation development and Quality Control
• GMP and Qualified Person support

Jörg Täubel

Expert for cardiac safety in drug development

Jens Hoffmann

Expert for Research and Drug Discovery in Oncology

• Validation and characterization of oncology targets
• Tumor models, stem cells
• Biomarker identification, translational research

All clinical testing needs planning and all available data needs to be interpreted. Clinical drug development is very expensive and if you want to find the right path to approval, you need the best target product profile, development plan and study design.

If you are considering to invest in a drug or are preparing a strategic decision inside your company you want to evaluate the quality of the available data and estimate how and when this product could get to the market. Let us introduce you to our team of independent experienced consultants who can support you with medical, scientific and statistical expertise, experience and know how.

CONELIS Experts offer Consultancy and Support for:

• Clinical program and study design Phases I-IV
• Evaluation of data for strategic decisions
• Safety risk management
• Interim Management
• Support of submissions to authorities
• Conduct of Expert Meetings, advice on biomarker programs

Contact person: Astrid Schott

Topics:

The experts are:

Siglinde Dürr

Expert for Quality Assurance

• Implementation of Quality Systems according to GMP, GCP or ISO regulations
• Conduct quality audits (GMP/GCP/ISO)
• Develop and implement Standard Operating Procedures
• Project management of funded projects

Wolf-Stefan Richter

Expert for Clinical Development

• Study design and imaging biomarkers
• Medical need assessment
• Medical regulatory strategy

Anke Maaßen

Expert for In Vitro Diagnostics (IVDs)

• Regulatory Affairs (EU regulations: IVDD and IVDR)
• Quality Management and Assurance
• Internal and Supplier Audits
• Support for Manufacturing and Control

Daniel Sehrt

Expert for Early Clinical Research & Development

• Scientific concept & design of Phase I-IIa trials
• Clinical pharmacology (PK/PD and pharmacogenomics)
• Clinical trial applications

Jörg Täubel

Expert for cardiac safety in drug development

Christian Hucke

• Clinical and non-clinical Project Management
• Interim Management, Strategy
• Clinical Operations, Clinical Study Management
• Quality Risk Management

Hans Hendriks

Expert for Pre- and Early Clinical Drug Development

• Scientific and Regulatory Medical Writing (Oncology, Inflammatory Diseases)
• Non-Clinical and Early Clinical Anticancer Drug Development

Johannes Lampe

Expert for Clinical Research & Development

• Clinical development, Phase I-IV (Neurology, Immunology)
• Medical regulatory strategy
• Due diligence

Christian Wolf

Expert for Clinical Development & Life Cycle Management

• CNS indications (MS, epilepsy, stroke)
• Strategy, operations and interim management
• Business development

Astrid Schott

Expert for Clinical Research & Development

• Clinical Development planning, Phase I-III
• Interim management
• Due Diligence, licensing

Michael Zimmermann

• Expert for conformity assessment according to Regulation (EU) 2017/745 (MDR)
• Clinical investigations and clinical evaluations
• PMCF
• Technical documentation and Design Dossiers
• Seminars and training courses on clinical investigations and clinical evaluations

Frank S. Zollmann

Expert for Pre-/ Clinical Drug Development

• Safety pharmacology, toxicology, pharmacogenomics
• Integrated preclinical & clinical development up to PoC
• Clinical pharmacology

Development and testing of drugs and medical devices is a complex process, which is highly regulated by Health Authorities. This also requires being compliant with authority requirements in production of a device or medicinal product throughout its life cycle. We provide our expertise to navigate the regulatory maze with its large number of guidelines, to stay compliant and to propel your project forward as fast and efficient as possible. Our goal is to develop and protect your projects' value.

Based on our extensive knowledge and experience with numerous development projects, successful submissions and marketed products we offer pragmatic proposals and solutions for your project:

CONELIS Experts offer Consultancy and Support for:

• Practical experience for Regulatory Compliance
• Design and implementation of Regulatory Strategies
• Customer oriented project management for most cost effective analyses and tests according GLP and ISO

Contact person: Michael Zimmermann

Topics:

The experts are:

Anke Maaßen

Expert for In Vitro Diagnostics (IVDs)

• Regulatory Affairs (EU regulations: IVDD and IVDR)
• Quality Management and Assurance
• Internal and Supplier Audits
• Support for Manufacturing and Control

Michael Zimmermann

• Expert for conformity assessment according to Regulation (EU) 2017/745 (MDR)
• Clinical investigations and clinical evaluations
• PMCF
• Technical documentation and Design Dossiers
• Seminars and training courses on clinical investigations and clinical evaluations

Siglinde Dürr

Expert for Quality Assurance

• Implementation of Quality Systems according to GMP, GCP or ISO regulations
• Conduct quality audits (GMP/GCP/ISO)
• Develop and implement Standard Operating Procedures
• Project management of funded projects

Besides providing help for all stages of product development until market approval, CONELIS also offers a wide range of expertise to support commercial insight, strategy, and success. Life science companies and investors in the field have the regular task of evaluating the commercial prospects of products or portfolios, which requires a sound understanding of market dynamics. Our consultants will help to thoroughly assess the facts and minimize risk. We are experienced to serve the pharmaceutical, biotechnology and medical device industry and offer external or hand-on support for business development, product commercialization strategies, financing or partnering deals, portfolio planning, and due diligence. We are internationally networked to facilitate transaction needs. In addition, we offer advice on the entire range of intellectual property rights to cope with the competitive challenges of development, manufacturing and commercialization of life science products throughout the world. We also offer services related to corporate design with the goal of clearly communicating the company's values and products, attracting attention, and creating recognition and trust.

Whatever it is you are looking for it is our intention to provide you with our competent knowledge as a basis for your strategic decisions and commercial success. Some of our experts are also available to fill executive positions as interim managers who can hit the ground running.

CONELIS Experts offer Consultancy and Support for:

• Commercial Assessment and Market Research
• Portfolio assessment and corporate strategies
• In- and Outlicensing Support
• Due Diligence Support
• Financing Support
• Intellectual Property Law
• Corporate Design

Contact person: Nicola Henneberg-Busse

Topics:

The experts are:

Nicola Henneberg-Busse

• Partnering & in-/out-licensing
• NPV calculations, commercial assessments
• Deal valuations
• Market research, competitive analyses
• Commercial strategies
• Business plan writing

Moritz Hillgenberg

Expert for Commercial Insight and Strategy

• Opportunity assessment, forecasting, valuation
• New product positioning and commercial strategy
• Portfolio assessment and priorization
• In-/out-licensing support

Sebastian Tegethoff

Expert for Intellectual Property Law

• Patent prosecution, litigation, due diligence and Freedom to operate analysis
• Trademark and Design prosecution and litigation
• Licensing and German Law relating to employee invention

Thomas Fink

Expert for Corporate Finance

• Corporate and Project Financing
• Succession and M&A
• Interim and part-time management / CFO services

Christian Nagelstrasser

Expert for Visual Strategy

• Corporate Design, Brand Development
• Webdesign, Social Media
• Graphic Design, Medical Drawing