Areas of Expertise

CONELIS experts cover the entire value chain of life science from early discovery to product commercialization.

Chemistry, Manufacturing and Control

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:

Michael Hildebrand

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

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)
Bettina Pahlen

Bettina Pahlen

Expert for CMC, Quality Assurance

Mónica Unger-Bady

Mónica Unger-Bady

Expert for Regulatory Compliance in Pharmaceutical Industry

  • Analysis, individual consultation, implementation
  • Project management, interim management
  • Business analysis
  • Coaching and Training
Ulf Tilstam

Ulf Tilstam

Expert for CMC, Chemical Process Development, R&D

Siglinde Dürr

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

Non-clinical Research and Development

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:

Michael Hildebrand

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
Jürgen Conrad

Jürgen Conrad

Expert for public funding of R&D

  • Identification of European funding opportunities
  • Planning of R&D projects according the funding rules
  • Coordinating of contract negotiations
  • Project management of funded projects
Bernd Schmidt

Bernd Schmidt

Expert for neuropsychiatric drug development

  • preclinical and clinical (Ph I-IV) drug development
  • regulatory support, interim management
  • positioning, market access
Pascal Piller

Pascal Piller

Expert for Project Management and Contract Research

  • Full range Test Laboratory Service for REACH/Preclinic
  • Regulatory Affairs Service / Material Safety Data Sheets
  • Product safety-tests, in-vitro tests and SVHC analyses
Matthias Bräutigam

Matthias Bräutigam

Expert for drug research and preclinical development

  • Imaging agents
  • Imaging technologies
  • Medicated devices
Wolfgang M. Roßberg

Wolfgang M. Roßberg

Expert for non-clinical drug safety and development

  • Investigative toxicology
  • Regulatory toxicology
  • Evaluation of in-/out-licensing candidates
Hans Hendriks

Hans Hendriks

Expert for Pre- and Early Clinical Drug Development

  • Pre- and Early Clinical Anticancer Drug Development, Project Management
  • Scientific and Medical Writing
  • EU-grant applications and Management of grant-funded Projects
Sanna-Maria Käkönen

Sanna-Maria Käkönen

Expert for non-clinical development

  • Scientific Marketing
  • Scientific Writing
  • Oncology
Frank S. Zollmann

Frank S. Zollmann

Expert for Pre-/ Clinical Drug Development

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

Jens Hoffmann

Expert for Research and Drug Discovery in Oncology

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

Clinical Development

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:

Hans Hendriks

Hans Hendriks

Expert for Pre- and Early Clinical Drug Development

  • Pre- and Early Clinical Anticancer Drug Development, Project Management
  • Scientific and Medical Writing
  • EU-grant applications and Management of grant-funded Projects
Marc Esser

Marc Esser

Expert for Market Access and Medical Communications

Wolf-Stefan Richter

Wolf-Stefan Richter

Expert for Clinical Development

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

Michael Zimmermann

Regulatory Affairs and Medical Devices

  • Expert for conformity assessment according to EU directives
  • Medical device quality management
  • Medical device clinical affairs
Frank S. Zollmann

Frank S. Zollmann

Expert for Pre-/ Clinical Drug Development

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

Johannes Lampe

Expert for Clinical Research & Development

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

Christian Wolf

Expert for Clinical Development & Life Cycle Management

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

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
Mark Waring

Mark Waring

Expert for Safety Risk Management

  • Safety risk management strategy and plans
  • Epidemiological study design
  • Operational support in pharmacovigilance
Bernd Schmidt

Bernd Schmidt

Expert for neuropsychiatric drug development

  • preclinical and clinical (Ph I-IV) drug development
  • regulatory support, interim management
  • positioning, market access
Erwin Böhm

Erwin Böhm

Expert for Clinical Research & Development

  • Translational Medicine
  • Clinical Development Phase I-III (Dermatology, Cardiovascular, Oncology)
  • Interim Management
Astrid Schott

Astrid Schott

Expert for Clinical Research & Development

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

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
Carsten Schwenke

Carsten Schwenke

Expert for Biostatistics

  • Statistical planning of Clinical Development, Phase I-IV
  • Submissions for marketing authorization
  • Health economics and outcomes research

Drug Regulatory Affairs and Compliance

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: Birger Kintzel

Topics:

The experts are:

Pascal Piller

Pascal Piller

Expert for Project Management and Contract Research

  • Full range Test Laboratory Service for REACH/Preclinic
  • Regulatory Affairs Service / Material Safety Data Sheets
  • Product safety-tests, in-vitro tests and SVHC analyses
Siglinde Dürr

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
Mónica Unger-Bady

Mónica Unger-Bady

Expert for Regulatory Compliance in Pharmaceutical Industry

  • Analysis, individual consultation, implementation
  • Project management, interim management
  • Business analysis
  • Coaching and Training
Michael Zimmermann

Michael Zimmermann

Regulatory Affairs and Medical Devices

  • Expert for conformity assessment according to EU directives
  • Medical device quality management
  • Medical device clinical affairs
Bettina Pahlen

Bettina Pahlen

Expert for CMC, Quality Assurance

Birger Kintzel

Birger Kintzel

Expert in Regulatory Affairs for the EU, USA and International territories, covering both pharma and biotech products

  • Regulatory strategy and submissions
  • CTAs und Scientific Advice preparation
  • Life-cycle management

Business Strategy & Development, Intellectual Property and Corporate Design

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:

Andreas Hey

Andreas Hey

Expert for Interim Management

  • Sales & Marketing (world-wide)
  • Business Development
  • General Management (CEO & COO)
Nicola Henneberg-Busse

Nicola Henneberg-Busse

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

Claas Junghans

Patent Attorney

  • Strategies for IP protection, IP portfolio due diligence
  • Patent application drafting and prosecution
  • Licensing negotiation, term sheets and contracts
Thomas Fink

Thomas Fink

Expert for Corporate Finance

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

Christian Nagelstrasser

Expert for Visual Strategy

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

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
Marc Esser

Marc Esser

Expert for Market Access and Medical Communications

Nils Matzen

Nils Matzen

Expert for Interim Management

Jürgen Conrad

Jürgen Conrad

Expert for public funding of R&D

  • Identification of European funding opportunities
  • Planning of R&D projects according the funding rules
  • Coordinating of contract negotiations
  • Project management of funded projects
Moritz Hillgenberg

Moritz Hillgenberg

Expert for Commercial Assessments and Market Research

  • Commercial Opportunity Evaluation
  • Product Positioning and Forecasting
  • Primary and Secondary Market Research
Silke Sittner

Silke Sittner

Expert for Interim Management