Product registration can be a rather confusing and challenging task. Each country has its own unique product registration requirements and classification systems.
F7 Global can assist you in registering your medical device. Our regulatory experts are diligent in preparing and reviewing medical device registration documents. We will take all the necessary steps to minimize additional documentation requests from the approval body and other delays.
Analyze the dynamics of registering your medical device in your target market.
Medical device registration is a seemingly simple process of submitting applications and supporting documents to the appropriate regulatory bodies of each country. However, a deep understanding of the applicable regulations and complex requirements — which are significantly more extensive than what is available in published resources and tutorials — is essential to ensuring that your submissions comply with the regulations.
Conduct a gap analysis (if necessary)
Determine if local clinical trials are needed for registration
Prepare and manage regulatory documentation as required.
We will review the dossier and other documents, including documents related to quality management system compliance, foreign manufacturer accreditation, etc.
Address any questions or requests from the government agency.
We will schedule and attend in-person meetings with the approval agency on behalf of the client.
Obtain approval and send the final registration approval certificate to the client.
To find out more about how we can assist you with the medical device registration process, contact us now for a free consultation with our regulatory experts.
Streamline the registration process for your pharmaceutical product with the help of our regulatory specialists.
The pathway to obtaining registration approval for drug products can oftentimes be lengthy and difficult. The regulatory agencies in each country have their own unique set of regulations and requirements that must be followed, and any mistakes or oversights in your initial application dossier can lead to significant delays in the registration process.
F7 Global can help pharmaceutical companies find the most time- and cost-efficient way to apply for registration in their target market. We specialize in complex registrations and work with our clients to successfully obtain approval by offering the following services:
Review the client’s product and establish the most effective approach to registration
We will closely study your drug product’s specifications and determine the necessary steps of the application process. There are many regulatory requirements and potential pitfalls that are not clearly delineated in easily accessible resources and tutorials. Thus, a thorough understanding of the regulatory system and submission requirements in each country is crucial to ensuring a smooth, successful approval process.
If necessary, conduct a gap analysis of the client’s product
Assess whether local clinical trials are required for the client’s product
Prepare all the requested documentary requirements for submittal to the regulatory agencies
We will carefully review and prepare the application dossier, including materials regarding quality management systems, foreign manufacturer accreditation, etc.
Respond to any questions or requests from the regulatory agency
If in-person meetings are requested by the regulatory body, we can attend the meetings on the client’s behalf.
Provide the final registration approval certificate to the client upon receiving it from the regulatory agency
To find out more about how we can assist you with the pharmaceutical product registration process, contact us now for a free consultation with our regulatory experts.