Biopharma Regulatory & Compliance

 

Make it count...

Drug development takes a considerable amount of resources to achieve feasibility.  You shouldn't take the same approach to determine a regulatory strategy for your drug, biologic, vaccine, vitamin or generic.  Rubix LS is here to help navigate your path as Life Science is in our name.  

 
 
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boosting regulatory affairs

You have a great product that's either near completion or already there.  Next you have to start the regulatory submission process.  We are the experienced team that acts on your behalf, as a third party, to ensure efficient management of the submission process is thoroughly executed.  

Handling elements such as:

  1. Pre-Clinical 
  2. Clinical
  3. Pharmacokinetics
  4. CMC
  5. Drug Safety

is where we effectively overcome these tasks on your behalf with our team.  With our novel submission portal, we're able to mitigate 98% information deficiencies that would usually require a follow up response to any regulatory agent.  

 
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Strengthening your strategy...

You're underway with the regulatory submission process but are a little overwhelmed with requirements needed during the process.   Strengthen your team with ours, to carefully overcome challenges before, during and after the preparation process.

  1. Regulatory Strategy
  2. Pre-IND
  3. IND
  4. Clinical Trials
  5. Pre-NDA/BLA
  6. NDA/BLA Prep & Submission
  7. Approval
     
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    control your quality

     Current regulatory standards require that quality systems ensure safe drug manufacturing and clinical trial oversight; these systems must include established processes for regulatory compliance and risk mitigation.  Establishing an intelligent framework of GCP and GMP audit and development is not only smart but also vital.  

    Rubix LS is here to help you tackle those challenges sustaining quality in number of measures, all while you control the direction of your needs.  Whether it's from Good Clinical Practice audits, Good Manufacturing Practice needs and establishing/strengthening your Quality Management & Assurance System. Show the regulatory bodies you're a well oiled machine with our help.