You innovate. We navigate.

For more than 14 years we navigate companies through the regulated pharmaceutical environment in the fields of GMP, Quality Management and Drug Regulatory Affairs. Our approach is to take all involved disciplines on board to achieve the objectives. Only then the journey called innovation can be successful.

Pharmaceutical Advice

  • Drug Regulatory Affairs Strategy
  • Pharma 4.0
  • Pharmaceutical Quality System
  • Quality Risk Management
  • Knowledge Management

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Compliance

  • GMP Compliance & Assessment
  • GMP Auditing
  • eCTD, PACM, QbD
  • Technology Transfer
  • Data Integrity

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Training

  • E-Learning
  • PhactSheets
  • Inhouse Training
  • Workshops

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Designing Quality

Doing it right the first time requires a holistic approach to optimize the processes (development, manufacturing, business) in your firm. Phact elaborates solutions which are sustainable and easy to implement in your operating environment. We accompany your firm all the way through to marketing authorization of your drug product by establishing a Pharmaceutical Quality System and regulatory strategies.

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E-Learning

In today’s fast changing environment new formats of know-how transfer for the employees need to be applied. The utilization of digital media enables individual and interactive learning. Training becomes more focused, self-explaining and can be applied just-in-time independently from the location. Corporate customers can book the fee-based access to the Phact e-learning platform online.
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Pharma 4.0

The pharmaceutical industry is undergoing a transformation process from industrialisation (Pharma 2.0) towards digitalisation (Pharma 4.0). This process will require significant changes in the way of operating. Along this way a number of factors and pre-conditions need to be implemented for moving forward. Phact supports pharmaceutical companies on the way to the future.

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Managing Directors

Phact Management Director Dr. Barbara Jentges

Dr. rer. nat. Barbara Jentges

Specialist for Drug Regulatory Affairs, CEO

“As an experienced Drug Regulatory Affairs specialist, I am aware how company internal processes should be coordinated best in order to achieve marketing approval of a complex product. It is important that all employees, from the management down to the experts, act together.”

Phact Management Director Dr. Lothar Hartmann

Dr. rer. nat. Lothar Hartmann

Expert for Quality Management & GMP, CEO

„Due to my extensive experience working in international companies, at operational level as well as on global level, I am aware of the requirements and expectations towards Pharmaceutical Quality Systems and GMP. My advice is pragmatic and focused.”

E-Learning, Workshops and Regulatory News

Phact Blog Workshop Auditing

Workshop Auditing – The Professional Use of Auditing Techniques

The Professional Use of Auditing Techniques Requires Exercise Some of us feel uncomfortable when talking about audits. And indeed, a number of audits lack of efficiency, miss systematic approaches, demonstrate
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SPOR – EMA’s Concept to Implement ISO IDMP Standards

SPOR – EMA’s Concept to Implement ISO IDMP Standards
 

‘SPOR’ – you are reminded of your Latin lessons during school years long ago and it is ‘SPQR’ that emerges before your mind’s eye? Mind the difference – the little stroke that makes the latin letter “Q”.
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EU: GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions

EU: GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions

Separate legal provision for ‘GMP for IMPs’ and for ‘GMP for medicinal products’ The legal framework for conducting clinical trials within the European Union (EU) has undergone major revisions and
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“If you want to build a ship,
teach the men to yearn for the vast and
endless sea.“

Free Adaption based on Antoine De Saint-Exupéry

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