AcertiPharma is your partner for EU Market Release and more

Our 3 QP’s can each assess your products’ API and bulk batch manufacturing records, laboratory tests, leading to EU release conform your marketing authorization.

When applicable AcertiPharma manages deviations, out of specs and investigations. If deemed necessary, we can contemplate and support in any market action.

The system in which EU release takes place, is fully compliant with EU GMP and Annex 16. Thus, we can also qualify the involved supply chain, see also the Supply Chain section

We specialize in consultancy, support, advise and submission of various license applications and variations.

We will partner you through any application for a Manufacturing and Import Authorisation / Wholesale Distribution Authorisation / API GDP registration.

In the current complex global supply chains that exist for pharmaceutical product we are your partner to deliver a fully qualified supply chain, through audits/ evaluations/ risk assessments and dossier build of all GxP relevant actors your company is partnering with.

The ultimate deliverable is an approved vendor list for your product.

market access

AcertiPharma has extensive knowledge and experience on distribution to EU markets through importation and wholesaling. AcertiPharma has a proven track record in enabling market supply in markets which kept closed so far. Do you want to know how? We are happy to tell!

Regulatory Affairs is a service provided by AcertiPharma for more than 20 years, already. Do you need a general assessment of your dossier or system or a detailed analysis? Do you need to submit a full dossier or need temporary support in RA Maintenance? You are at the right place for knowledge of the EMA procedures and systems, like Centralised/ MRP/DCP/ Trackwise, Documentum, CESP, Artwork Generation.

AcertiPharma is known for professional assistance with all Quality Affairs related projects, like GMP and GDP optimization, GDP/ GMP auditing, license applications for pharmaceutical manufacturer, wholesaler, narcotics, creation/ review or update of your Quality Management Systems.