Regulatory Strategy Consulting for Pharmaceuticals

 

Navigate the complicated regulatory systems with the assistance of our expert regulatory consultants.

Regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each country has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with regulatory affairs can be a very difficult task.

F7 Global's approach to designing regulatory strategy employs our strong understanding of the European markets and regulatory systems to enable our clients to make confident, actionable decisions. We specialize in assisting pharmaceutical and biotechnology companies with their most difficult, complex endeavors in Europe, and can help our clients to develop intelligent solutions in all areas such as product registrationreimbursement, and local agent representation.

Discussion

When crafting a regulatory strategy for your pharmaceutical product in each European market, there are four important questions that should be considered:

  1. Does your regulatory strategy incorporate an understanding of the constantly shifting requirements and regulatory environment in each European country?
    The regulatory agencies in Europe frequently announce revisions and updates to their drug regulations. What are the newest regulations in each European country for clinical trials? How are the drugs classified? What are the documentary requirements for product registration? We always keep up with these changes in order to eliminate any uncertainty for our clients.

  2. Does your regulatory strategy account for potential issues that may delay the approval of your drug product?
    Unwanted problems and obstacles that slow down the approval process for your pharmaceutical product may arise. We will help you proactively identify potential challenges and devise creative solutions to bypass and resolve these issues ahead of time, so that no unexpected issues interrupt the registration of your product.

  3. Does your regulatory strategy utilize the most efficient pathway to register your pharmaceutical product in Europe?
    Our thorough understanding of the European regulatory systems can help our clients reduce the time and costs necessary to obtain product registration for their drug products. For example, in some cases, local clinical trials can be avoided, or the costs can be partially covered by your local partner. We will help you determine the most time and cost effective way to obtain approval for your pharmaceutical product.

  4. Does your regulatory strategy include a plan to obtain a competitive reimbursement price for your drug product?
    In many European countries, procuring a high reimbursement price for your drug product is crucial if you want to compete with other products on the market. Our expert consultants will assist you with obtaining reimbursement status and a profitable reimbursement price for your pharmaceutical product.

To learn more about the regulatory pathway and registration requirements in each European country, please select your target market: Contact us today for a free consultation with our European regulatory consultants on developing a regulatory strategy for your pharmaceutical product in Europe.

Regulatory Strategy Consulting for Medical Devices

 

Our seasoned experts can guide your medical company through the complex regulatory pathways in Europe.

Business Meeting

The regulatory process from product design to market entry for a new medical device or IVD is oftentimes complicated and unclear. In Europe, it can also become difficult to make a clear distinction between your regulatory strategy and business strategy. For example, if your international sales and marketing executive signs agreements with distributors who lack expertise on the local regulatory approval process, registering and selling your medical products could become a very challenging process.

F7 Global’s European medical device consulting services can help your medical company develop an intelligent, effective strategy to obtain product registration approval and access the medical markets in your targeted European countries. Our robust knowledge of Europe’s medical device regulations and effective strategic plans have assisted numerous clients with proactively eliminating risks and uncertainty, while maximizing the potential for commercial success. We work closely with our clients to solve their most complex regulatory problems in areas such as product registration, reimbursement, quality compliance, local agent representation, and clinical trials.

There are several key factors that should be considered when developing a regulatory strategy for your medical device product in Europe:

  1. Does your regulatory strategy include consideration of the constantly changing regulatory environment in the European markets?
    New medical device regulations and approval requirements are released on a regular basis. We are always keeping track of these updates so that you can be caught up immediately. What products can be classified as medical devices or in vitro diagnostics according to the official definition? What documents are required to be submitted? Whose name can a foreign medical company register their medical product under? We have the answers to all these questions and more.

  2. Does your regulatory strategy proactively identify challenges or issues that may delay approval of your medical device?
    Not only will we pinpoint potential obstacles so that you can avoid any unexpected roadblocks during the registration process, our regulatory consultants will help you define innovative solutions and approaches to circumvent these challenges ahead of time.

  3. Does your regulatory strategy identify the most cost-effective way to get your medical product registered?
    For example, can foreign clinical data be used for product registration or are there local clinical trials required? If they are required, is your local partner willing to assist with the associated costs? We can help you assess the fastest and most efficient registration pathway for your medical product.

  4. Does your regulatory strategy correctly identify the key success measures to obtain product reimbursement?
    Obtaining reimbursement status is essential for your sales performance in Europe; however, the process can be complicated. Our experts have the knowledge and experience with official reimbursement procedures necessary to procure a competitive price for your medical product.

F7 Global’s European medical consulting is your finger on the pulse of Europe’s booming medical device industries. Our expert consultants have assisted many of our international clients with identifying efficient, actionable strategies for product classification, registration, and reimbursement.

We specialize in complex projects that require innovative strategic thinking and deep industry knowledge. To read about specific examples of regulatory strategy projects that we have successfully completed for our clients in the past, please select a target market below. Companies interested in introducing their medical devices or expanding their business into Europe can contact us for guidance on developing a successful regulatory strategy.