Our experts can support you with regulatory strategies for both APIs (DMF, ASMF, CEP, JMF) and marketing authorisation for drug products both in regulated markets and rest of the world.
- Legal basis of MA application based on EU Directive 2001/83/EC.
- Generic medicinal drug product application – Art. 10(1)
- Hybrid medicinal drug product application – Art. 10(3)
- Bio-similar drug product application – Art. 10(4)
- Well established use application based on literature – Art 10a
- Combination dosage forms application – Art. 10b
- Selection of Reference Medicinal Product (RMP)
- Identifying suitable Reference Member State (RMS)
- USFDA: ANDA, BLA application
- UK MHRA MA applications
- Brazil – ANVISA
- MA application support for other territories include: Japan, Brazil, Canada, Australia, Taiwan and rest of the world
- Market feasibility study
- Change-control assessment and classification of variations
- Support with post-approval change management protocols. With an approved change management protocol, the change can typically be classified as at least one category lower than the actual variation category described in the EU variation guidelines.
- Support with strategy to identify and qualify new suppliers of raw materials for drug products and reagents / starting materials/ intermediates for API synthesis.