Services We Offer

Our core focus is to offer supportive services to Regulatory Departments of Pharmaceutical Companies in the field of Regulatory affairs.

We have been involved with all aspects of regulatory affairs right from Dossier compilation to all regulatory activities involved in the life cycle management of pharmaceutical medicinal products.

Our experience in regulatory affairs profession covers the following areas of work:

• Compilation of dossiers for submission to various regulatory agencies all over the world
  (in CTD format)

• Work on regulatory assignments / projects allocated from the multinational companies (clients) .

• Submission of new marketing authorisation, change of ownerships, renewals and variations as per the current regulatory guidelines for medicinal products globally.  

• Submission of country specific regulatory Dossier or Conversion of Dossier from NTA to CTD format. 

• ‘Gap Analysis’ which is a meticulous review of the dossier to check it’s Suitability for submission to regulatory authorities.

• Compliance Audit.

• All regulatory activities related to Lifecycle management of medicinal products.

• Carrying out any task delegated by client which contribute to overall running of Firm e.g. assistance with different on-going projects.  Accurate and timely delivery on projects.

• We work on diverse range of projects around the globe .

• Review of the existing dossiers for improvements.

• All kind of due diligence.

• We also convert your dossier from Notice to Applicants (NTA) format or paper CTD to eCTD and electronically publish your MAAs.

• Nitrosamine impurity risk assessment reporting to Agencies