Our Services
GMP and GDP Audits
NDA/MAA Submissions
Our experienced auditors can ensure that your site or facility around the world is up to current standards and inspection ready for EU or FDA inspections.
We provide support and guidance to help you achieve your GMP certification or Wholesale dealer's Licence.
Lifecycle Maintenance
We can take care of all your regulatory commitments in Lifecycle maintenance including variations, MAH transfers, renewals, US Annual Reports, PSURs/PSUSAs with a dedicated case manager who can continuously assist you throughout your journey.
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Business Development
Help you set up a local contact points in various countries, new suppliers of API or external testing labs. Let us see how we can expand your business.
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Let us strategise, prepare, author, collate and publish your MAA/NDA/ANDA/BLA submissions including pre-submission meetings and scientific advice.
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Pharmacovigilance
​EV registration, SPS and RMP review
EU QPPV and Deputy EU QPPV
NSO / LQQPV services
GVP audits
Housing of PSMF location in the EU
MAH location services in the EU
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eCTD Authoring
Ever thought of outsourcing your compiling and authoring of dossiers and concentrate on other stuff? We offer practical solutions in the world of publishing dossiers using eCTD manager.
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