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 What are Your Needs?
 Why should You Retain Us?


 
  What are Your Needs?
  With the ever increasing focus on safety mandated by health authorities throughout the world, regulatory compliance is more than ever a prominent issue for you yet you have to cope with the growing complexity of regulations affecting your products and processes. While you are willing to abide by all requests from the authorities, you find it difficult to stay abreast of regulatory changes.

You strive to implement a regulatory organization which is as efficient and stable as possible, but you also have to keep it up-to-date as to today's and tomorrow's standards and rules permanently evolve towards more complexity.
You are looking for advice and support to help you streamline your internal team of regulatory and/or pharmaceutical affairs and to provide them with the following services:
Evaluate the regulatory feasibility of a project and check its compliance with existing or future regulations:
 
 - regulatory due diligence on a product or on a global portfolio
 - review of promotional material.
   
Carry out the necessary applications on your behalf where needed:
 
 - securing official registration required to serve an authorized distributor of pharmaceutical products
 - licensing of a pharmaceutical establishment.
   
Propose the optimal structure for your regulatory operations to match authorities' expectations:
 
 - flow optimization according to Good Practices
 - elaboration of procedures
 - regulatory training
 - awareness programs dedicated to staff in other departments in order to make them sensitive to regulatory constraints.
   



  Why should You Retain Us?
 
Comprehensive knowledge of healthcare regulation
Our consultants have been serving the regulatory community for several years. Our team comprises a mix of pharmacists with industry, administration and hospital experience, as well as lawyers specialized in health law.
   
An understanding of authorities’ expectations
We maintain a permanent watch of new laws and regulations and entertain the appropriate contacts with law makers and regulators so as to stay abreast of future changes. When draft regulations threaten our client's interests, we alert you and we are able to mount a lobbying effort to propose alternative measures.
   
Practical experience of regulatory submissions
We take great care in keeping and developing appropriate connections with regulators and we know at all times where and to whom your particular application should be submitted. We are able to provide you with the necessary templates, assist you in preparing your dossiers and make sure your submission will be validated and reviewed in a timely manner.
 
In-depth experience of information technology
Our consultants have hands-on experience in the evaluation and implementation of software aimed at addressing regulatory matters in the industry and in the hospital environment (i.e. coordination of vigilance, management of sanitary risks, etc.).
 
 


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