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Validation / Regulatory:

Complying with current regulations is an increasingly complex task requiring considerable resources and expertise. Whether you work in the packaging, clinical trials, pharma or biotech, R&D, actives manufacture, medical devices or secondary manufacture sector of the pharmaceutical industry, compliance with the regulations issued by the Medical & Heathcare products Regulatory Agency (MHRA) (previously the Medicines Control Agency (MCA)), Food and Drug Administration (FDA),World Health Organization(WHO ) ,or other authorities is essential to keep your organization up and running.

 

The logical and well proven approach to regulatory compliance provided by our experienced consultants/professionals , armed with real-world experience and a best – practices methodology , will provide your enterprise with the knowledge and resources required to meet the short term goals of current projects as well as the long term need of continued compliance.

 

Value Added Elements:

  • Cost effective and efficient route to compliance 

  • Quality assurance and process reliability at the best value

  • Reduced likelihood of non-compliance during inspection 

  • Independent 'best industry' advice 

  • Sector wide process to achieving compliance 

  • Experience of many industry-standard systems 

  • Enterprise-wide regulatory compliance consultancy capability 

  • Mutually beneficial partnership approach 

Other Services:

Validation Services
Validation Master Plan
Process Validation
Cleaning Validation
Computer Systems Validation
Qualifications: Facilities, Equipment & Utilities
Installation Qualification
Operational Qualification
Performance Qualification
Controls Automation Qualification
Assessments
Gap Analysis & Mitigation Planning
Compliance Assessment
Risk Analysis
Impact Assessment
Commissioning
Projects
Validation and cGMP Trainings
Standard Operating Procedure Development

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Telephone: (787) 625-1500  |  E-Mail: info@isspr.com
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