Consulting and Regulatory Services
ACPS provides customised expert services for the set-up, review and improvement of the development and regulatory strategy of novel drug products aimed for marketing authorisation in the EU, including due diligence; gap analysis; strengths, weaknesses, opportunities and threats (SWOT) analysis; scientific advice; centralised procedure (CP), decentralised procedure (DCP), mutually recognised product (MRP); and documentation creation according to EU Directive 2001/83/EC).
