Providing information on a regulatory environment and regulatory requirements should be informative enough to map your road to launch your business in a timely manner, and it should also ensure confidentiality, information protection and agility at the same time. We understand that you have many questions that are critical aspects of the projects on registration processes to relevant stakeholders and we provide a solution to each of these issues.
Your Question: What regulations and guidance document applies to our product?
Our Solution: Identification of regulatory requirements
Your Question: What division of the health authority will review our product and which stage will take place when?
Our Solution: Reporting on main steps and approximate timelines
Your Question: How much will it cost to get the final approval?
Our Solution: Regulatory budgeting including official and non-official costs
Your Question: Are there any previous steps to take before submission to apply the best strategy?
Our Solution: Pre-submission and prioritisation correspondence
Your Question: What additional documentation required from our side in addition to the available core documentation?
Our Solution: File compilation, document tracking and submission of a marketing authorisation application
Your Question: What if are there any updates to the existing products?
Our Solution: Change impact assessment and update submission to the approved marketing authorisation approvals (variations, renewals, change of marketing authorisation holder)
Your Question: Do we have to travel and visit the authority each time when needed?
Our Solution: Representation at the health authorities (regular and ad hoc basis)
Your Question: After the MAA submission, what if we get questions/deficiency letters or official requests from the health authority?
Our Solution: Guidance and compilation for the response filing for deficiencies and official requests
Your Question: The regulatory environment is frequently changing and the notice period is usually short, and we do not read in the local language. Are we going to give guidance on the changes?
Our Solution: Maintaining an awareness of regulatory changes in legislation and guidance
Your Question: How are going to cope with the changing environment?
Our Solution: Assessment of impact
Your Question: What price does get our product?
Our Solution: Pricing strategy and guidance on a prospective pricing
Your Question: How and when is our product going to get approval for its local price?
Our Solution: Compilation of required documentation for pricing and follow-up of the procedure
Your Question: Is it likely that our product will be reimbursement by the healthcare provider?
Our Solution: Reimbursement strategy and calculation of a possible reimbursement price
Your Question: Is it possible to show our product’s value to the healthcare provider based on our global strategies?
Our Solution: Model adaptation to local needs
Your Question: What are the full requirements for an HTA submission?
Our Solution: Compilation of an HTA submission for reimbursement and follow-up of the procedure
Your Question: Do we have to travel and visit the health care provider each time needed?
Our Solution: Technical and official representation at the healthcare provider
Your Question: The marketing authorisation approval procedure is lengthy, and we need to start sales as soon as possible before the final approval. Is there a regulatory route for early access?
Our Solution: Early Access System Support which includes Market search for the product’s niche, visiting the key stakeholders and procedure follow-up
Your Question: We need a commercial partner to market and sales for our product.
Our Solution: Information about the local players and initiation of cooperation
Your Question: We need a local player to be the marketing authorisation holder until we set our M&S team and launch the product.
Our Solution: Our sister company can be used as a local marketing authorisation holder for your product