TOPICAL MEDICAL DEVICES
Project design planning
Regulatory strategy
APR is certified by TÜV SÜD and all our quality systems conform with UNI CEI EN ISO 13485: 2012. APR works closely with authorities in Europe and the USA to provide the best regulatory strategy to meet our clients' requirements. An accurate classification study according to the relevant country's directives ( 93/42/EEC and related amendments in the EU and 510K in the USA) is mandatory. APR also manages scientific advice meetings with regulatory/health authorities.
TOPICAL MEDICAL DEVICES
Project design planning
Selection of the best
delivery system
APR's experienced team of scientists has an in-depth knowledge of a given product's physical and chemical characteristics - fundamental in determining the optimal formulation and dosing characteristics properly addressing our client's and patient/consumer needs.
TOPICAL MEDICAL DEVICES
Project design planning
Investment plan
APR conducts comprehensive time and cost analysis as an integral and fundamental part of the design process.
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