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.
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.
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.
“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.”
„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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