Preclinical development is crucial both in adding value to a drug and in admission to clinical trials.
We work jointly with you to develop the right strategy.

Non-Clinical Development

We work with you to develop the preclinical development strategy for your product and jointly we carry out the non-clinical development. We support you in the preparation and submission of all regulatory documents (IND, CTA, IMPD, NDA, BDA, CAP) both within and outside the ICH area. We take responsibility for the identification of the right CROs to ensure the adequate quality standards (GLP, ISO). We advise and support you in the implementation of quality assurance systems in preclinical development (QA, GLP, training seminars, audits).

Non-Clinical Development Strategy

Preclinical development determines the added value of a drug in its early stages, from initial identification and optimisation of the lead compound to development and safety testing of the proposed clinical drug candidate. Approval for clinical trials includes the collection of data on pharmacology, toxicology and ADME / DMPK of the drug substance. Ideally, the new drug will show optimum chemical, physical and biological properties. 

  • non-clinical development strategy
  • early drug development plan
  • target product profile (TPP)
  • pharmacology
  • ADME/DMPK
  • non-clinical development team

It will demonstrate a conclusive efficacy and safety profile supporting patient convenience through appropriate forms of application with optimum absorption, distribution and elimination of the active ingredient. The foundations for success are laid in early preclinical and clinical development.

We support you in preparing a preclinical development plan for admission into Phase I clinical trials (Early Drug Development Plan). We create the Target Product Profile (TPP) of your product jointly with you, as the basis for development and optimization of your drug and as one component of a successfully presentation to potential investors and licensees. We provide you with the basis for determining which data to collect in-house in your own laboratories and which data may be obtained through outsourcing.

Where necessary, we set up effective development teams (non-clinical development teams) for you, and act as the representative for NCD in interdisciplinary development teams (core development team). We support you in the optimum preparation of all the data for financing or out-licensing.

Non-Clinical Development Strategy

Preclinical development determines the added value of a drug in its early stages, from initial identification and optimisation of the lead compound to development and safety testing of the proposed clinical drug candidate. Approval for clinical trials includes the collection of data on pharmacology, toxicology and ADME / DMPK of the drug substance. Ideally, the new drug will show optimum chemical, physical and biological properties. It will demonstrate a conclusive efficacy and safety profile supporting patient convenience through appropriate forms of application with optimum absorption, distribution and elimination of the active ingredient. The foundations for success are laid in early preclinical and clinical development.

We support you in preparing a preclinical development plan for admission into Phase I clinical trials (Early Drug Development Plan). We create the Target Product Profile (TPP) of your product jointly with you, as the basis for development and optimization of your drug and as one component of a successfully presentation to potential investors and licensees. We provide you with the basis for determining which data to collect in-house in your own laboratories and which data may be obtained through outsourcing.
Where necessary, we set up effective development teams (non-clinical development teams) for you, and act as the representative for NCD in interdisciplinary development teams (core development team). We support you in the optimum preparation of all the data for financing or out-licensing.

  • non-clinical development strategy
  • early drug development plan
  • target product profile (TPP)
  • pharmacology
  • ADME/DMPK
  • non-clinical development team

Early Development

Jointly, we will identify the in vitro and in vivo pharmacology and ADME/DMPK studies that you will need within the targeted indication, in order to characterise your product and obtain the necessary data for approval for clinical trial.
  • efficacy
  • pharmacokinetics
  • biodistribution
  • CRO selection
Working with you further, we identify the CROs to carry out experiments and studies, work together with you on the study plans, monitor the studies at the CRO and assist you in the interpretation, assessment and presentation of results in the submission documents (IND, CTA, IMPD, NDA, BDA, CAP). We jointly prepare the results of early or academic studies and report them in the appropriate formats.

Early Development

Jointly, we will identify the in vitro and in vivo pharmacology and ADME/DMPK studies that you will need within the targeted indication, in order to characterise your product and obtain the necessary data for approval for clinical trial.
Working with you further, we identify the CROs to carry out experiments and studies, work together with you on the study plans, monitor the studies at the CRO and assist you in the interpretation, assessment and presentation of results in the submission documents (IND, CTA, IMPD, NDA, BDA, CAP). We jointly prepare the results of early or academic studies and report them in the appropriate formats.
  • efficacy
  • pharmacokinetics
  • biodistribution
  • CRO selection

Safety Testing

The safety tests on drug substance for approval for clinical trialsare subject to stringent legal requirements in terms of scope (FDA/EMA/PDMA Guidelines) and quality (GLP).

Despite the stringent regulation, the test strategies for individual drug classes differ and furthermore are greatly influenced by individual company objectives (indication, regions for approval, milestone planning, financing models, licensing models).

  • safety testing strategy
  • toxicology
  • safety pharmacology
  • FDA/EMA/PDMA guidelines
  • maximum safe starting dose in humans (MRSD)
  • minimum anticipated biological effect level (MABEL)
  • CRO monitoring
Jointly we develop your individual safety testing strategy and carry out the test program for you. This includes identification of the ideal CROs, qualification and auditing of the CRO, and study monitoring of the experiments and research studies assigned, all in strict adherence with the principles of GLP. We assess and interpret the data received and prepare it for presentation and submission to the regulatory authorities. We assist you in estimating the starting dose for initial use in human clinical trials (MRSD/MABEL) and determining the safety margin.

Safety Testing

The safety tests on drug substance for approval for clinical trialsare subject to stringent legal requirements in terms of scope (FDA/EMA/PDMA Guidelines) and quality (GLP). Despite the stringent regulation, the test strategies for individual drug classes differ and furthermore are greatly influenced by individual company objectives (indication, regions for approval, milestone planning, financing models, licensing models).
Jointly we develop your individual safety testing strategy and carry out the test program for you. This includes identification of the ideal CROs, qualification and auditing of the CRO, and study monitoring of the experiments and research studies assigned, all in strict adherence with the principles of GLP. We assess and interpret the data received and prepare it for presentation and submission to the regulatory authorities. We assist you in estimating the starting dose for initial use in human clinical trials (MRSD/MABEL) and determining the safety margin.
  • safety testing strategy
  • toxicology
  • safety pharmacology
  • FDA/EMA/PDMA guidelines
  • maximum safe starting dose in humans (MRSD)
  • minimum anticipated biological effect level (MABEL)
  • CRO monitoring

Regulatory Submission

In order to submit for clinical trials or for the approval of a medicinal product, all non-clinical data must be summarised, interpreted and presented according to specific criteria.

We prepare all the submission documents (IND, CTA, IMPD, NDA, BDA, CAP) in CTD format, including the special requirement of individual regions (EMA, FDA, PMDA, etc.) and support you in the preparation of SEND files for submissions to the FDA.

  • preparation of official documents
  • CTD with non-clinical overviews and written and/or tabulated summaries
  • preparation for tregulatory authorities visits, scientific advice
  • SEND
  • preparation für IND, IMPD, CTA, NDA, BDA, CAP

Regulatory Submission

In order to submit for clinical trials or for the approval of a medicinal product, all non-clinical data must be summarised, interpreted and presented according to specific criteria.

We prepare all the submission documents (IND, CTA, IMPD, NDA, BDA, CAP) in CTD format, including the special requirement of individual regions (EMA, FDA, PMDA, etc.) and support you in the preparation of SEND files for submissions to the FDA.

  • preparation of official documents
  • CTD with non-clinical overviews and written and/or tabulated summaries
  • preparation for tregulatory authorities visits, scientific advice
  • SEND
  • preparation für IND, IMPD, CTA, NDA, BDA, CAP

GLP (Good Laboratory Practice)

Good Laboratory Practice (GLP) provides the quality basis for conducting all safety-related investigations during non-clinical drug development. GLP should ensure that data can still be verified, even after a lengthy period of time, and consequently that the results of past studies can be assessed in the light of new scientific developments.

Established on our  long lasting and multinational experience in GLP and Quality Assurance, we advise you on all aspects of GLP and provide you with a QA specialist. We take care of the requirements of regulatory authorities for you:

with outsourcing

  • CRO audits
  • audit reports
  • data verification and control

We can carry out the QA tasks either partially or fully:

  • facility audits
  • study specific audits
  • process based audits
  • system audits
  • support for qualification and validation of devices

in house

  • development of a GLP compliance program
  • GLP training seminars
  • development of a SOP system

Creation of all audit reports, qualification plans, validation plans and reports, and QA statements for you.

  • QA support
  • SOP system
  • GLP training seminars
  • data checking

GLP (Good Laboratory Practice)

Good Laboratory Practice (GLP) provides the quality basis for conducting all safety-related investigations during non-clinical drug development. GLP should ensure that data can still be verified, even after a lengthy period of time, and consequently that the results of past studies can be assessed in the light of new scientific developments.

Established on our  long lasting and multinational experience in GLP and Quality Assurance, we advise you on all aspects of GLP and provide you with a QA specialist. We take care of the requirements of regulatory authorities for you:

with outsourcing

  • CRO audits
  • audit reports
  • data verification and control

in house

  • development of a GLP compliance program
  • GLP training seminars
  • development of a SOP system

We can carry out the QA tasks either partially or fully:

  • facility audits
  • study specific audits
  • process based audits
  • system audits
  • support for qualification and validation of devices

Creation of all audit reports, qualification plans, validation plans and reports, and QA statements for you.

  • QA support
  • SOP system
  • GLP training seminars
  • data checking

We support you in the implementation of your goals and advise you on marketing and sales activities.

proceed