Apyx's services include compilation of submissions to the FDA and international regulatory authorities, process and technical consulting, training in regulatory document authoring and preparation of submission documents.
Products include templates that automate manual processes associated with document authoring, document preparation, label authoring and SPL conversion.
We focus exclusively on submissions processes and best practices, regulations and technologies, and have not diluted our focus over the years.
Apyx executives are highly experienced in the regulatory submissions space with critical insights into submission best practices and the proven ability to manage the submissions process despite highly demanding deadlines, disparate project teams, multinational considerations and other challenges.
Apyx values a high level of communication with clients, and our senior executives are readily accessible. We strive to provide complete transparency both operationally and contractually.
Apyx is a privately held corporation, founded in 2002 by current president and CEO Ken VanLuvanee. We are headquartered 30 minutes northwest of Philadelphia in Collegeville, PA.
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Case Studies
Learn more about representative projects and challenges that large and small pharma face in the area of regulatory submissions and how Apyx has helped meet these challenges.