The right Quality Strategy is of upmost importance to a company in a regulated environment. PRO Pharma Consulting can advise you in setting the right Quality strategy based on the scope, the applicable regulations and the overall company strategy.
Factors, impacting the strategy, are tyically (non-exclusive list):
- Pharmaceutical or MedTech Industry
- Type of activity: manufacturing, packaging, QC-testing, and/or distribution
- Type of manufacturing: starting materials, intermediates, APIs/Drug Substances, semi-finished products, finished products, packaging, market release
- Geographic scope: local markets or regional/global
- Overall company strategy in relation to QA & Compliance
- Potential evolvement of company in relation to products, activities, markets
In order to develop the Quality Strategy, a well defined Vision and Mission is essential.