Select Page

Smiro Qualitas Ltd

Areas of Expertise

The company expertise is in the following areas:

  • Qualified Person Certification and Release of batches;
  • Clinical Trials;
    • – Manufacture
    • – Packaging
    • – Distribution
    • – IRT
  • Quality Management Systems
  • Quality Assurance
  • Internal and External Auditing
  • Validation
  • Training
  • GxP Compliant Computer Systems
  • Supply chain management
  • Advanced Medicinal Therapeutic Products

About Us 

Smiro Qualitas Ltd is small independent business providing cost-effective, practical quality solutions for today’s pharmaceutical industry. It is owned by Robert Smith, a Pharmacist and Qualified Person, with over 25 years’ experience in the pharmaceutical industry.

The business can provide the following services:

  • Batch record review by an individual eligible to be a Qualified Person;
  • Batch Certification and Release of Product when named on a company’s MIA or MIA(IMP);
  • Training;
  • Setting up Quality Management Systems for new companies and departments;
  • Remediating Quality Management Systems after adverse regulatory inspections;
  • Auditing services;
  • Document reviews.

 

Business Credentials

With over 25 years’ experience in the pharmaceutical industry, covering all major sectors of the industry, Smiro Qualitas Ltd is well placed to provide affordable consultancy based support to your company.

You can choose to employ Smiro Qualitas to provide long-term contract Qualified Person cover or remediation of a Quality system, or on short-term assignments like internal and external audits and training assignments. As Robert has worked in large and small pharma companies and contract manufacturers, he has unique insight as to the differing requirements that each of these business models have. This means that Smiro Qualitas is able to customise its offering for each assignment and client.

Whatever assignment you give to Smiro Qualitas Ltd you can be sure that the work will be of a high standard that all issues will be thoroughly analysed and followed through, and that Smiro Qualitas will work with your business to meet agreed timelines.