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Why use us to help?

We have a proven track record in regulatory affairs with hands on experience of dealing with Health Authorities in many countries for many years.

We have experience in all aspects of a product development program. This includes the preparation and management of regulatory submissions for both clinical trials and marketing authorisation applications, and post-licensing regulatory support.

We have extensive experience of the pharmaceutical and allied industries and a comprehensive understanding of the ever-changing regulatory environment.

We are not daunted by new challenges brought by developing legislation. We have been working to help companies meet the legislative requirements of the new Traditional Herbal Medicines Directive, the Food Supplements Directive, and the Nutrition and Health Claims Regulation.

We also offer a comprehensive pharmacovigilance service to underpin all regulatory activities.  These include setting up robust PV systems to cope with the demands of your business, provision of an EU Qualified Person for PV (QPPV), preparing for an Authority PV inspection, and guiding you through other pharmacovigilance requirements such as electronic safety reporting and MedDRA coding.

We can offer experienced medical writers to support activities closely associated with our regulatory activities which include either business to business or business to consumer medical projects, such as product launch activities, compiling literature reviews, writing abstracts and/or poster content for symposia or patient education programmes.

At all times we aim to provide a professional service to you and work to ensure that all your requirements are met.