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At TRAQuE we understand the regulatory minefield that you need to negotiate to achieve and maintain your products on sale in the global pharmaceutical markets.

Finding, understanding and implementing the regulations can be a significant hurdle in achieving GMP certification. Target market requirements differ, and what might be acceptable in some countries may be contradicted by regulations in another country. Our experts have many years of experience in supporting customers to achieve compliance in multiple countries and regions.
Our experts have years of experience helping numerous companies achieve regulatory clearance to sell their products. We have extensive experience navigating the right path to regulatory approval. Our team can work with yours to bring them up to date on the latest requirements and expectations.
We have supported companies with continuous improvement projects, remediation work, and in responding to warnings and citations. Even if you know your regulations, implementing them in a practical and maintainable way can be difficult. We can help by giving you the right expertise and baselines so that you can continue to meet them.
We have worked with multinational corporations and small local companies in markets from China to Palestine, Japan to India, and Europe to the US. Our experience is global, but our knowledge is local. Whatever your target market, we can help you achieve compliance.
We can support you in the following activities:
  • Quality Assurance oversight
  • QMS Development and Implementation
  • Risk Assessment, Mitigation and Management
  • Deviation Management, Investigation and Remediation
  • CAPA and Continuous Improvement
  • Regulatory Inspection Readiness
  • New Product Dossier Preparation
  • Master File development
  • Auditing
  • Lifecycle Documentation Review
  • Part 11 and GAMP Remediation
We can give you practical and hands-on support in many activities, including
  • Updating Design History Files
  • Development of Device Master Records
  • Updating Product Specifications
  • Writing Manufacturing Methods
  • Product and Technology Transfer
  • Risk assessments (materials, suppliers, processes etc.)
  • Writing Disaster Recovery Plan
  • Updating Quality Plans
  • Updating Business Contingency Plans

We can help prepare practical and compliant SOPS including:
  • Batch Review and approval
  • Change Control
  • Deviation and CAPA Management
  • Rejects and recalls
  • Material receipt and storage
  • Shipping requirements
  • Labelling and tagging
  • Routine verification of equipment before operation
  • Line Clearance
  • Gowning
  • QC sampling and inspection
  • Qualification
  • Quarantine and release
  • Management of Device History Records
  • Review, Revision and Version Control

We can help you with your laboratory computerized systems, and give you practical advice and solutions on:
  • Data Integrity Checks
  • Gap Analysis
  • Compliance Remediation
  • Back-up Planning
  • Disaster Recovery Planning
  • Security Auditing and Verification
  • Automation procedures and practices


If you would like more information, please "Get On TRAQuE" and contact us.

Partners

Anville Instruments
dekon
Ezidock
iwws
koslow
palamatic
Protak Scientific
Solo 2
temprecord
TPE
I2SL
rsc

Office Address

OfficeLocation

Our contact details in Singapore are:

TRAQuE Pte. Ltd.
51 Bukit Batok Crescent,
#08-25 Unity Centre
658077
Singapore
+65 6316 3885
+65 9735 1384
+65 6316 3885
www.traqueasia.com
traque-pte-ltd

Our mailing address in Malaysia is:

TRAQuE Sdn. Bhd.
Suite 13-10, Level 13,
Johor Bahru City Square Office Tower,
106 - 108, Jalan Wong Ah Fook,
80000 Johor Bahru.

If you would like further information on our products or services, then feel free to contact us using the form below. We look forward to working with you.

Contact Us

Please contact us if you would like further information on any of our products or services. We will get back to you as soon as possible.

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Latest News

TRAQuE Awarded bizSAFE Star

TRAQuE is pleased to announce we have been awarded BizSafe Star by the WSH Council.

 

Congratulations to the team and well done in the continued efforts in supporting safety.

 

TRAQuE Malaysia

We’ve always placed great importance on being close to our customers. The ability to provide local resources, respond quickly and be onsite as required has proven extremely valuable in the seven years since we began operations in Asia.

 

Protak Scientific Partnership
Protak Scientific Logo

We're delighted to be kicking off our partnership with Protak Scientific in Singapore. This revolutionary alternative to biological indicators for use when assessing VHP effectiveness is significantly quicker than current methods and can provide linear quantitative data, resulting in optimised cleaning processes and increased productivity.

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