You innovate.
We navigate.

Pharmaceutical Advice, Compliance & Training (Phact)


Phact provides superior and innovative consulting for the pharmaceutical industry in the areas of Quality Management, GMP, Regulatory Affairs and Training. Requirements in Development, Manufacturing and registration of pharmaceutical products become more and more complex. We analyse your situation and design holistic strategies for the marketing authorisation process – ensuring that innovation is available as fast as possible for the people in need.

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Designing Quality


Doing it right the first time requires a holistic approach to optimize the processes (develop- ment, manufacturing, business) in your firm. Phact elaborates solutions which are sustain- able and easy to implement in your operating environment. We accompany your firm all the way through to market authorization by establishing a Pharmaceutical Quality System and Regulatory Strategies.

Pharmaceutical Advice

Drug Regulatory Affairs Strategy
Pharmaceutical Quality System
Quality Risk Management
Knowledge Management

Compliance

GMP GAP Analysis, Auditing
eCTD, PACM, QbD
Technology Transfer
Data Integrity

Training

E-Learning
In-house Training
Public Events

You innovate. We navigate.


For more than 12 years we advise companies in the areas of Quality, Quality Management, GMP and Drug Regulatory Affairs. Our approach is to take all involved disciplines on board to achieve the objectives. All of your experts need to participate on the journey called innovation.

Dr. rer. nat. Barbara Jentges


Dr. rer. nat. Barbara Jentges
Specialist for Drug Regulatory Affairs,
CEO, Phact GmbH

“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.”

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Dr. rer. nat. Lothar Hartmann


Dr. rer. nat. Lothar Hartmann
Expert for Quality Management & GMP
CEO, Phact GmbH

„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.”

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E-Learning

Regulated Phases of Drug Development

Regulated Phases of Drug Development. Non-Clinical (GLP), Clinical (GCP), Manufacturing (GMP)

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E-Learning

Quality by Design (QbD) – An Introduction

Quality by Design – An Introduction. The Pharma Quality Paradigm Shift.

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E-Learning

Quality Risk Management in Pharma

Quality Risk Management in Pharma. An Introduction.

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E-Learning

Quality Target Product Profile (QTPP)

Quality Target Product Profile (QTPP). How to Determine the Drug Product QTPP.

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Phact Sheet

Audit Agenda & Report

Formatted template in Microsoft WORD to create an audit-agrenda and an audit report.

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Phact Sheet

Quality Manual

Formatted template in Microsoft WORD to create a Company-specific Quality Manual according to ICH Q10.

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Workshop

1-Day-Workshop 'Pharmaceutical Quality System'

1-day workshop on 26 February 2019 to deepen your knowledge about implementing a PQS.

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Workshop

1-Day-Workshop 'Electronic Common Technical Document'

1-day workshop on 4 April 2019 to deepen your knowledge about creating an electronic Common Technical Document and avoiding common pitfalls



"If you want to build a ship,
teach the men to yearn for the vast and endless sea."

free adaptation based on Antoine de Saint-Exupéry