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In the pharmaceutical environment, especially in the development of generic drug products and in close cooperation with my network of experienced experts, I offer services in the following areas:

For FURTHER information on how I operate, please read more on METHOD.




In the pharmaceutical environment, especially in the drug development of generics and biosimilars, and in close collaboration with my network of experienced experts, I offer you services in the following areas:


  • Strategic planning, conception, or implementation of drug development in the area of (CMC, Safety, Efficacy, Regulatory)

  • Due diligence of product and license offers with a focus on manufacturability, quality, approvability, economic viability, COGS

  • IP: evaluation of the state of the art, freedom to operate

  • Carrying out root cause analyses, trouble shooting, finding solutions

  • Implementation of development methods such as quality by design, design of experiment, modelling, in vitro-in vivo correlations proof of concept studies

  • Experience with the development of various dosage forms and global approvals of, oral solids (tablets, capsules, monolithic, multidisperse; IR, CR, SR); sterile drug products (vials, pre-filled syringes, implants; solutions, lyophilisates), TDDS (transdermal drug delivery systems, patches), mucosa delivery systems, drug device combinations, medical devices

Entwicklungsbild mit Stift, Pinnbrett und Kapseln und anderen Arzneimitteln


  • Efficiency analysis, evaluation, proposals for improvement; support and/or implementation

  • Establishment of development products (technology, analytics) in the GMP environment, scale-up, process development, validations

  • Product transfers between routine production sites, life cycle management

  • Support in applying for or changing the manufacturer's permit, the site master file, in preparing inspections by EU, CIS* and US authorities

    * CIS - Commonwealth of Independent States created in December 1991 by eleven countries from the ex-USSR: Armenia, Azerbaijan, Belarus, Kazakhstan, Kirghizstan, Moldavia, Uzbekistan, Russia, Tajikistan, Turkmenistan, Ukraine. Georgia joined it in December 1993.



In our network of experienced experts, we tailor solutions for your project and are happy to accompany and/or implement them

  • EU, CIS, USA

  • Small molecules, large molecules

  • Regulatory strategy

  • Scientific Advice

  • INDs, IMPDs, dossiers, regulatory procedures

  • Support to answer deficiency letters and for regulatory changes

Unterzeichnen eines Vertrages


a) Project management

  • Evaluating, planning, managing, controlling and completing projects in pharmaceutical development

  • Development of the project-specific strategy and project plan with critical path, milestones, time and resource planning

  • Evaluation of the feasibility and risks of projects regarding technology, quality, effectiveness, safety and approval in the EU, USA, Eastern Europe. Evaluation of time to market, costs to market

  • Management of projects, reporting; escalation of unforeseen events, development of solutions

b) Department or site management

Management of teams, departments or sites as a temporary ad interim manager

Operationsmanagement erklärt von Dr. Karin Klokkers, gestikuliert mit ihren Händen vor dem Laptop


Your projects and your company will benefit from our values and our behaviour:

  • High level of understanding and interest in achieving your goals due to our broad professional and management experience with various teams

  • Result-oriented, entrepreneurial thinking and action

  • Collegial leadership style, demanding and promoting

  • Interdisciplinary, constructive cooperation with different departments and hierarchical levels

  • Openness and transparency combined with the ability to communicate quickly and situationally

  • Enjoyment of the task and constructive exchange

  • “Hands on” mentality, pragmatism

  • Our team is multilingual, fluent in German and English, good knowledge of French, Slavic languages

Besprechung mit Chefin


I work on many projects with experts in project-specific teams.

Our advantages over a permanent team are:


  • Flexibility: we adapt our team to the project-specific needs in terms of expertise and effort

  • Specialisation: we bring in experts for specific areas and deliver tailor-made solutions

  • Agility: we can react quickly to changes and develop innovative approaches

  • Cost: You pay for the resources actually needed for your project

  • External perspectives: with us as externals, you will gain new ideas and perspectives for your topic and your project



Due diligence examination of an offer for a drug approval:

  • Verification of supply chain, GMP status, quality control

  • Checking whether and how regulatory requirements are met, e.g. B. regarding the “structured approach to development”, the similarity requirements for biosimilars for the EU

  • In the case of using devices in a medicinal product, what about an assessment by a notified body or the CE mark

  • Freedom to Operate

Papierstapel und Arzneiproben symbolisieren Prüfberichte für Arzneimittelverwendung
Due Diligence


Let us discuss your project, your questions and possible solutions in a non-binding conversation.

Please feel free to contact me by email or telephone to arrange a non-binding initial consultation.

I'm looking forward to our conversation!

Best regards,
Yours, Karin Klokkers

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