For over 10 years Dr. Jeanette Haney has been helping the small- and medium sized pharmaceutcal companies to meet the legal requirements for drug delivery and to make their drugs safe.
Nobody manages to achieve great things alone. That’s why Dr. Haney and her 10-strong team can look back on more than 21 companies that have achieved sustainable GVP compliance with his strategies.
If you want to get better Pharmacovigilance solutions than your in-house team could ever effort then do not hesitate and get in touch!
QPPV Availability & Support
ICSRs managed
Pharmacovigilance Audits
CEOs, QPPVs and Heads of Regulatory Affairs from 22 different international pharmaceutical companies have already been able to use our modular Pharmacovigilance and RA solutions to develop their projects model in a predictable, sustainable and scalable way. Together we will find out which building blocks you currently need to achieve Regulatory and Pharmacovilance security for your drug sales.
With our tried-and-tested systems and process guidelines, you build your drug sales on an absolutely secure pharmacovigilance foundation in compliance with GVP that runs as reliably as a Swiss watch.
To do this, you involve the trustworthy colleagues of Dr. Haney Pharma, who manage the day-to-day QPPV business for you.
Pharmacovigilance audits are important columns of a Pharmacovigilance system. They shall be carried out by someone, who is not directly involved in the processes. Many companies do not have enough experienced and impartial staff to fulfill this requirement. We do.
Our PV auditors are well-trained and experienced to evaluate the PV processes of your own company or your partners (distributor or service provider audit).
The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) replaces PSURs with a signal detection analysis at least annually as part of the signal management process.
We take over the implementation of the new VET PV system and annual entry of a conclusion on the benefit-risk balance for each medicinal product in the EMA database.
You are planning a concrete project in the regulatory field of Marketing Authorisation – e.g. MA transfer, changes in the manufacturing process / manufacturing site?
You think of a bigger improvement in the packaging information texts or a new application for Marketing Authorisation?
Our Regulatory Affairs experts find for you the best Regulatory strategy to make your project real!
Pharmaceutical companies are requiered to make it possible for physicians, pharmacies and patients to contact them during business hours for medical enquiries, quality defects and complaints.
We offer to take over this task on behalf of the MAH. Our Medical Information process ensures that the answers to such enquiries are given in a medically and scientifically
correct manner and in conformity with the marketing authorisation.
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3 simple steps to start our collaboration
With just one click, no more.
Choose a date that suits you and we get to know each other soon .
Each project starts with a consultation. You tell us what you intend to do – we will advise you on whether, how and in what time frame the project can be implemented. We will find a common, consensus-based solution.
We choose the appropriant team for your individual project and support you with our quality documents to make your suppliers qualification as easy as possible. Then we can set up the processes and start with a joint kick-off meeting
