Applying for a marketing authorisation is a bit like a marathon. You need perseverance and a good preparation.
Dr. Haney Pharma supports small and medium-sized pharmaceutical companies in meeting the legal requirements for drug marketing authorisation submissions.
Ranging from clinical trial applications to new drug applications (NDA), variations, renewals, pharmacovigilance tasks, risk-management plans, and safety update reports, the company provides a flexible, customisable and cost-effective service.
Drug regulatory affairs services
Dr. Haney Pharma’s regulatory affairs services help guide clients through the authorisation and registration of medicines. Each project starts with a consultation session to discuss project implementation and find a consistent solution.
Dr. Haney Pharma GmbH
Dr. Haney Pharma will prepare any application for marketing authorisation and file it with the competent authorities. The company also writes and edits applications for the non-European market, including the US.
Its regulatory affairs services include corresponding with authorities and stakeholders, responding to regulatory inspection reports and deficiency letters; preparation and submission of clinical trial applications, NDAs, preparation and filing of Variations; adapting product information on the patient information leaflet (PIL) or summary of product characteristics (SmPC), labelling, advertising brochures and educational materials; and the creation and maintenance of electronic common technical documents (eCTD).
Regulatory dossier management
Dr. Haney Pharma offers a formal and professional examination of approval documents and adapts them to content changes. It revisits specialised information, instructions and labelling to convert them into the required format.
The company transfers drug dossiers into common technical document (CTD) or eCTD format.
Pharmacovigilance system master files (PSMF)
Dr. Haney Pharma offers a complete pharmacovigilance (PV) system consisting of PV services and the creation of a PV system master file (PSMF). Marketing authorisation holders (MAH) can also book PV services separately.
Available services include literature searches and analysis, safety reporting and signal management, submission of individual case safety reports (ICSR) to Eudravigilance, and the creation and management of standard operating procedures (SOP), periodic safety update reports (PSUR), risk management plans and benefit-risk evaluations.
The company also helps MAHs to systematically compile and evaluate safety-relevant data to meet the requirements of the European Medicine Agency (EMA).
Qualified person for pharmacovigilance and graduated plan officers
Dr. Haney Pharma sources a specialist qualified person for pharmacovigilance (QPPV) that meets regulatory guidelines.
In Germany, the company assumes the tasks of the graduated plan officer according to the German Medicinal Law, such as overseeing PV, product defects and reclaims.
The company also acts as a batch releaser and fulfils information officer tasks for product information and advertisement materials.
Dr. Haney Pharma offers a range of PV audit services, including consulting for audit preparation, support during audits, and compliance advice.
eXtended Eudravigilance medicinal product dictionary
Dr. Haney Pharma maintains marketing authorisations in the eXtended Eudravigilance medicinal product dictionary (xEVMPD), including validating and maintaining software and securing communication with the EMA.
Professional matchmaking service
Dr. Haney Pharma provides a professional matchmaking service for developers, MAHs, distributors and drug substance and final product manufacturers.
The company provides:
- Contacts to manufacturers
- Medicinal product dossiers ready for submission
- Drug development/improvement of the drug formulation
- Clients for marketing authorisations
About Dr. Haney Pharma
In January 2018, Dr. Haney Pharma was awarded the German Prize for Excellence in the ‘Manager and Doer’ category by the German Institute for Service Quality.
The company maintains contact with its customers to keep marketing authorisations up to date and ensure regulatory compliance throughout the lifecycle.
Dr. Haney Pharma has a quality management system (QMS) and every member of staff gets consistent training (internal and certified external courses) to stay on top of relevant regulations and developments.
All marketing authorisation Holders need someone to take good care of drug safety. Dr. Haney Pharma offers tailored services from complete pharmacovigilance systems to individual counselling, report writing, case study reporting or other tasks related to drug safety.
When your identified active substance has been shown to be effective, non-toxic and non-carcinogenic in non-clinical tests, the next step will be the planning and application for clinical trials.