We Are Your Pharmaceutical compliance and regulation Partner
Welcome to ACERTIPHARMA, your trusted partner in pharmaceutical compliance and regulatory solutions.
With a team of seasoned professionals—Wouter van Berckel, Rutger Smit, and Eric de Wit—we bring unparalleled expertise to the pharmaceutical industry. Our specialists are QP/RP listed, ensuring the highest standards of quality and compliance.
We offer services including senior auditing, interim management, and regulatory affairs, tailored to meet the evolving needs of your business. Additionally, we serve as a reliable EU release hub, streamlining the release of products across the European market.
At ACERTIPHARMA we are committed to excellence and delivering solutions that foster success in the highly regulated pharmaceutical landscape. Explore our services and let us support your journey to compliance and growth.
Our Fields of Expertise
EU batch certification
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
License applications
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.
Supply chain qualification
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
EU 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
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.
GXP support
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.
Our Clients
Let’s Talk
PHARMA
Want to learn more about our solutions? Talk to our experts.