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SERVICE

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:
 

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

KLOKKERS PHARMA CONSULTING GMBH

DRUG DEVELOPMENT & PRODUCTION

SERVICE

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:

DEVELOPMENT

  • 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
Entwicklung

PRODUCTION

  • 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.

Impfstoff-Produktionslinie

REGULATORY AFFAIRS

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
Zulassung
Produktion

MANAGEMENT

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
Management

LEADERSHIP

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

TEAM OF EXPERTS

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

Labor

DUE DILIGENCE

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

THE START OF A SUCCESSFUL PROJECT

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.

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I'm looking forward to our conversation!

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Best regards,
Yours, Karin Klokkers

 

E-mail. karin.klokkers@gmx.de
Mobile. +49 171 4703379

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