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Pharma Consulting.

Tailor-made advice to optimize your processes and ensure regulatory compliance.
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Compliant?

Meet all regulatory requirements with our professional support.

Holistic?

Benefit from comprehensive support in all phases of your pharmaceutical projects.

Efficient?

Maximize your efficiency and minimize risks through optimized processes.

Ensure the success of your pharmaceutical projects.

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Our core competencies in Pharma Consulting.

Our pharma consulting services offer you comprehensive support in all areas of the pharmaceutical industry.

Our experienced consultants support you in optimizing your pharmaceutical processes so that you can meet regulatory requirements efficiently and on time. With our support, you can ensure that your products not only meet the highest quality standards, but also receive the necessary approvals.

Whether preparing and conducting clinical trials, managing regulatory requests or implementing robust quality management systems, we can provide you with the strategic advice you need. Our goal is to successfully implement your projects from the planning phase to market launch by minimizing potential risks and maximizing efficiency.

With our holistic approach to pharma consulting, we support you at every stage, from regulatory compliance to clinical development and process optimization. Our consulting services cover all important aspects that are necessary for success in the pharmaceutical industry.

Discover our expertise in pharma consulting.

Our pharma consulting expertise covers all relevant areas to ensure that you comply with regulatory requirements, optimize processes and bring innovative products to market.

Quality management.

  • Quality management & compliance
  • CAPA management and SOP development
  • GxP inspections and audits
  • Qualification & validation

Manufacturing Science & Technology (MS&T).

  • Technology excellence and clean supply chain operations
  • Sustainability strategies for pharmaceutical production
  • Technology transfer and lean manufacturing
  • EHS (Environment, Health, Safety) and capability building

Regulatory Affairs.

  • Regulatory strategy and CMC support (Nonclinical & Clinical)
  • Life cycle management and dossier creation
  • Communication with health authorities

Medical, Clinical, PV.

  • Medical Affairs and Medical Writing
  • Audits and GCP inspections
  • QPPV and signal detection
  • Sustainable clinical project management and monitoring during the recruitment and onboarding of laboratory specialists

Successful consulting projects in pharma consulting.

From quality management to technology transfer and clinical projects - our solutions are practical and effective.

Challenge.

A medium-sized pharmaceutical company was having difficulties aligning its quality management processes with GxP requirements. This led to delays in audits and an increased risk of compliance violations.

Measures.

  • Implementation of a robust quality management system (QMS) to comply with GxP guidelines
  • Conducting training courses on CAPA management and SOP development
  • Preparation for audits through simulated inspections and comprehensive risk assessments

Results.

  • 100% compliance in audits without complaints
  • 20% shorter preparation time for GxP inspections

Success.

The medium-sized company was able to significantly improve its audit capability and meet all GxP compliance requirements.

Meet regulatory requirements efficiently.

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Comprehensive pharma consulting services at a glance.

Our Pharma Consulting Services cover all key areas of the pharmaceutical value chain. With a deep understanding of the latest trends and regulations, we support you in the successful implementation of your projects - from development to market launch.
Our experts will guide you through the entire approval process, from submission to global health authorities to adaptation to regional standards. Our comprehensive regulatory affairs support ensures that your products meet global regulatory requirements. We offer specialized advice on topics such as ICH Q9 for risk management, GxP compliance, and support you in dossier preparation and Good Manufacturing Practice (GMP) compliance.
Our approach to quality management helps you to meet the highest standards in the pharmaceutical industry. We use lean methods and digital tools to continuously improve your processes and reduce costs. This includes implementing CAPA systems, optimizing your quality management systems (QMS) and ensuring compliance with ISO and GMP.
Digitalization plays a central role in the pharmaceutical industry. We support you in implementing modern data systems that guarantee both efficiency and security. Our services include ensuring data integrity, complying with data protection guidelines and using advanced analytics to make informed decisions. We also integrate AI-based solutions to accelerate your development processes and meet regulatory requirements.
Innovation management is essential in a rapidly changing market environment. We support you in the introduction of new technologies and the optimization of your development processes. Our service includes technology transfer from research to production to ensure that your products meet the highest quality standards and are successfully brought to market.

Ensure the success of your pharmaceutical projects.

Arrange consultation now