Drug Regulatory Affairs and Pharmacovigilance Services
For small and medium-sized pharmaceutical companies who would like to outsource their mandatory regulatory and pharmacoviglance duties. So they will take advantage from their company resources for the development of their business.
- Is it possible to buy adequate regulatory and pharmacovigilance expertise from outside?
- Do you have to decide between the flexibility of a freelancer and the service quality of a professional service provider?
- Is there someone who takes over regulatory work on an ad hoc basis and also has a regulatory view as a whole?
- Can I combine the flexibility of a freelancer with the quality advantages of a professional service provider to fasten and optimise my own projects?
The answer is YES – even more!
The solution for workaday life is provided by the Dr. Haney Pharma expert team and is reflected in their structured and controlled principle of operation.
“We have worked very successfully with Dr. Haney Pharma GmbH in connection with the submission of variations according to EU specifications. The communication in advance was always goal-oriented. All agreed deadlines were reliably met.”
Regulatory Affairs Services
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.
Dossier update / CMC
We offer you a formal and professional examination of your marketing authorisation documents and adapt them, e.g. according to your changes in manufacturing or after new regulatory requirements. By staying in direct contact with you, we will always keep you up to date.
We offer you a complete Pharmacovigilance system. Alternatively, Marketing Authorisation Holders can also book Pharmacovigilance services separately. With our custom-made solutions Marketing Authorisation Holders can easily comply with legal requirements. Weiterlesen…
If product changes have to be reported to the authorities, we prepare the variations and submit them to the regulatory authorities. This concerns changes according to the EU-Variation Guideline, but also national changes according. We also process non-European variations (e. g. USA.)
e-Submission und eCTD
We convert your drug dossiers into CTD format and provide you with an eCTD structure on request.
Pharmacovigilance audits are important issues 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.
“The [Pharmacovigilance] audit went very well and we cannot thank Mohammed Shoeb enough for his knowledge, expertise and communication in conducting a very productive audit.”
“The cooperation works very well. The staff is very competent.”
This post is also available in: German