Proven Track Record
- Serum Institute of India (Pune). Support in the design and construction and implementation of quality systems for three new buildings including two vaccines and one sterile finished dosage form. FDA approved.
- Assistance in start-up and quality systems for Protein Sciences (Meriden U.S.). FDA approved.
- Long-term support for Boehringer Ingelheim IT, (Biberach, Germany). FDA approved.
- Long-Term QA support for Roche (Mannheim, Germany). FDA approved.
- WHO Prequalification audit and support for Yuxi Walvax (China).
- Acambis (Cambridge U.S.) QA support in startup and operation of a vaccine manufacturing plant. FDA approved.
- Genibet (Lisbon, Portugal). Design Qualification of a Biotech Manufacturing facility and QA support to Licensing. EU approved.
Our Advantages
Global Experience
Our consultants have performed a significant number of assignments globally, in a range of different industries.
Broad Knowledge
We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.
Seasoned Consultants
Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
Overview of Our Services
Click here to contact us if the service you require is not listed below.
- GAP Analysis and Benchmarking
- Risk Assessments of (Proposed) QA Systems
- Development of Pharmaceutical Quality Systems & Quality Culture
- Definition of Suitable Metrics for Quality Monitoring and Improvement
- Practical Implementation Support of Entire Quality Systems or parts thereof
- Coaching and training of personnel at all levels within the organization in the principles and practice of Quality Systems
- Independent inspections to determine ongoing compliance to in-house, corporate or official Quality System requirements
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- World Health Organization (WHO) Qualification
- World Health Organization (WHO) Pre-Qualification
- Russian Good Manufacturing Practices (SID & GP)
- Indian National Regulatory Authority (NRA)
- Other National Regulatory Authorities
