Regulatory Par Excellence

     
     

Phone/Fax:+ 61 2 8013 6776

Mobile: + 61 415 706 915

Email: laurence.garceau@regexcel.com

   

 

COMMITMENT
       

Looking for someone to embrace your project as if it were their own?
Looking for strategies to accelerate your time to results or supplement your in-house skills?
Expecting technical expertise, high attention to detail and a proven track-record of success?
 

Regulatory Par Excellence is the answer.
 

aWe are truly passionate about your needs;

aWe work to the highest standards of quality;

aWe deliver on timelines;

aWe work independently whilst keeping you fully apprised of progress.

   

 

EXPERTISE
        Global Regulatory Affairs   Global Pharmacovigilance
        Services include the following and their related activities:   Services include:
       
  • Marketing Authorisation/Category 1/New Medicine applications, variations (including Category 3 applications, Safety-related Notifications) and renewals;

  • Preparation of product information documents (physician and patient);

  • Orphan designation applications;

  • Fast-track/accelerated assessment applications;

  • Scientific advice/protocol assistance applications;

  • Paediatric investigation plans;

  • Clinical Trial applications and notifications;

  • Meetings with Regulatory Agencies (e.g. for scientific advice, pre-submission);

  • General administration and procedures relating to pharmaceutical regulatory documentation.

 
  • Preparation of Periodic safety update reports (PSURs) and clinical safety reports;

  • Standard operating procedures;

  • Preparation for inspections, including summary of pharmacovigilance systems.

     

The primary consultant has over 11 years experience in the pharmaceutical industry, working in Europe and Australia, in Regulatory Affairs and Pharmacovigilance, including at senior management level.

Services at your offices are available if preferred.