Our Services

GMP/GDP/PV Services and Audits

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. 

Providing all PV requirements including PSMF, QPPV and PV system set-up in the UK and EU. 

 

New MAA Submissions

Let us strategise, prepare, author, collate and publish your MAA/NDA submissions for the EU, US, LATAM, MENA region and more. 

 

Recruitment
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. 

 

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. 

We deliver recruitment solutions at every stage of the process in all Life sciences roles. We strive to form long-term partnerships with skilled individuals, teams and whole organisations. 

 

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. 

 

Need more details? Contact us

We are here to assist. Contact us by phone, email or via our Social Media channels.