Applying for a marketing authorisation is a bit like a marathon. You need perseverance and a good preparation.
Apart from your brilliant ideas for a new product or the courage to file for a new generic, you will need some money in the background. In case you depend on external financial backers, it is important to present a clear and realistic timetable. From Dr. Haney Pharma’s experience in pharmaceutical companies, the company can advise you to plan your project in a reasonable and workable way.
Dr. Haney Pharma will guide you through the regulatory jungle and help you to find the smartest way to get your marketing authorisation, whether you want to sell in one country, in several countries, continent-wide or worldwide. The company will take over the administrative tasks, communicate with competent authorities, bring together all required documents, write and review reports and dossier pages and finalise the submission. During the whole process, you will always know where we are and what is the next step.
No matter from what point you start, Dr. Haney Pharma will support you with services such as finding a suitable partner for non-clinical or clinical trials, helping to get the best formulation, tracking down a well-trained qualified person for pharmacovigilance (QPPV), discussing the best strategy for your planned project.
Variations: regulatory compliance
The world is changing and so is your medicinal product, its texts or its manufacturing. Updates must be submitted in a certain form called electronic common technical document (eCTD), which includes various documents, certificates and reports. The requirements for this procedure are changing constantly.
Thanks to Dr.Haney Pharma’s experience and training, the company finds the best solution to adapt your medicinal product and to keep you and your dossier up to date. If you entrust Dr. Haney Pharma with your product or project, it will keep track of any legislative change so that you can be sure that you meet all requirements. Thus, lifecycle management of your product will run efficiently.
Five years after the initial marketing authorisation the renewal is due. This means you will have to provide information on aspects such as sales numbers, reported side effects, any changes in the supply chain or pharmacovigilance system, an updated risk management plan and good manufacturing practice (GMP) certificates.
Dr. Haney Pharma helps you to keep track of every requirement and prepares every document on time so that your renewal can pass smoothly. Preparations should start 12 months before the renewal date. Depending on the country, documents have to be submitted several months (often nine months) in advance.
Once renewed, marketing authorisations are usually given unlimited validity. However, you will have to monitor drug safety throughout the lifetime of the product. If there are safety concerns, you may have to file for another renewal after five years.