GVP compliance in times of specialists shortage?

The Best Way for Modern Pharma Companies To Defy The Ever-Increasing Regulations

Get more information now in a no-obligation consultation

Optimization of Pharmacovigilance Systems

We analyse the quality of your PV system and your costs.
You see where you are currently investing too much time or money.
You can then optimise the efficiency of your safety system with us and are guaranteed to pass the next PV inspection!

Pharmacovigilance Audits -Made in Germany

Meet Your GVP Audit Obligations Easily, Save Valuable Time and Work More Efficiently

Global Pharmacovigilance Solution

The All-in Care Package
EU-QPPV / Deputy and PV-Team

Local Pharmacovigilance Solution

Your Local Hub in Germany
Stufenplanbeauftragter, Information Officer

Regulatory Affairs Service

New Drug Application
Life-Cycle Management
National and Centralized Procedures

eSubmission Service

eCTD Compilation
PSUR Submission
CESP Submission

Interim Positions for Pharmacovigilance and Regulatory Affairs

We provide you with temporary support in all areas of pharmacovigilance and regulatory affairs – whether operational or in positions as responsible person, with expertise in GVP, pharmaceutical regulatory affairs or both as well as in-depth knowledge of ICSR management, signal management or other PV and RA relevant procedures.

The story of Dr. Haney Pharma

 
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From school to a PhD in Pharmacology

From school to PhD

Early steps as a freelancer

Building a team of specialists

Winner of the German Excellence Award

Looking into a prosperous future

Open up undiscovered potential with Dr. Jeanette Haney

There are a few word that aptly describe Dr. Haney:

Reliability – Sustainability – Fairness – Innovation – Appreciation

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.

She supports them with the core topics that are essential for every pharmaceutical company:

  1. Build Pharmacovigilance processes that fit to your company and to your drug portfolio and which are compliant to GVP
  2. Build local PV processes for Germany, if the MAH is settled down outside Germany and function as their German (PV and distribution) hub
  3. Take over responsibility as EU-QPPV, Stufenplanbeauftragter or Information Officer (and make available their deputies)
  4. Audit the GVP compliance of MAHs PV system and distributors
  5. Prepare MA variations, compile eCTD sequences and electronic submission

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.

Our processes have been proven in two BfArM inspections and more than a dozen clients` audits

If you want to get better Pharmacovigilance solutions than your in-house team could ever effort then do not hesitate and get in touch!

24/7

QPPV Availability & Support

1,235+

ICSRs managed

15+

Pharmacovigilance Audits

10+

Years of experience

Get your guide to GVP compliance now in a no-obligation consultation

How the Dr. Haney´s Pharmacovigilance system works to establish your GVP compliance

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.

Pharmacovigilance for Human Drugs

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

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).

Regulatory Affairs Service

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!

Get your guide to GVP compliance now in a no-obligation consultation

Veterinary Pharmacovigilance

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.

Medical Information Service

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.

Electronic Submission Service

You are looking for a fast and cost-effective solution to get valid eCTD sequences ready to submit?

You would like to have somebody who cares for your PSURs to be submitted in the right format and to be uploaded to the EMA Gateway?

Then you are right here. We appreciate to support you in these matters.

This is what awaits you

  • Smart Processes

    Proven Strategy on how to set-up a safe and cost-effective PV system. Always result-oriented and with impeccable quality of the documents

  • Personal contact person

    A fixed personal contact person for the project. Clients say, our colleagues are wonderful persons to work with. You will like to turn to us.

  • Transparent costs

    We use the best time tracking system ever – „Clockodo“ – to provide maximal transparency in our work. You receive detailed time sheets about all work items.

This is what our clients say:

Dr Haney and her team are very professional. She also gets things done and is a wonderful person to work with. Sometimes you get better solutions than your in-house team could ever dream of.

The chemistry is right – I’ll be happy to approach you. A fixed personal contact person for the project. They know the processes in companies and know what you want. Deliver at the agreed time and are open and transparent, which means no surprises.

“The [Pharmacovigilance] audit went very well and we cannot thank Dr. Haney´s GVP auditor enough for his knowledge, expertise and communication in conducting a very productive audit.”

 
Get your guide to GVP compliance now in a no-obligation consultation

Discover your next action to achieve GVP compliance

3 simple steps to start our collaboration

1. Get in touch by phone

With just one click, no more.

Choose a date that suits you and we get to know each other soon .

2. Free personal consultation

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.

3. Set-up of project team and processes

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

Call up your free consultation

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