Pharmaceutical
regulatory affairs consulting
Pharmaceutical Regulatory Affairs Consulting
Pharmaceutical regulatory affairs demands consistency from early development through to post-approval lifecycle management. AML Global prepares CTD/eCTD dossiers, manages IND and CTA submissions, and handles EMA and national authority filings, including liaison with AEMPS and MHRA. Our GMP compliance consulting covers EU GMP Annex requirements and ICH standards, supporting manufacturers through inspection preparation, gap analysis, and supplier qualification. The same senior team handles the full lifecycle.
Frequently asked questions
Can you help with an EMA submission for a generic medicine?
Yes. Generic marketing authorisation applications follow the same CTD/eCTD structure as any other application, built around the reference medicinal product and bioequivalence data. We prepare the dossier and manage the submission and the regulator's questions, whether through the EMA centralised procedure or national and decentralised procedures with agencies such as AEMPS.
Do you prepare CTD/eCTD dossiers?
Yes. We prepare CTD/eCTD dossiers for marketing authorisation applications and manage post-authorisation lifecycle submissions, such as variations and renewals.
What does your GMP consulting cover?
We support manufacturers against the EU GMP guidelines and annexes and ICH standards, including gap analysis, inspection readiness and supplier qualification.
Do you deal directly with the regulatory authorities?
Yes. We handle communication with the EMA and with national authorities such as AEMPS (Spain) and MHRA (United Kingdom), as well as with the FDA for submissions in the United States.