Why Choose CHIARA?

From small start-ups to large well-established manufacturing, design, technology or NHS spin out companies CHIARA offers a flexible and tailored RA and QA consultancy support service.  CHIARA can support you in meeting global regulatory and quality requirements from product inception to launch enabling fast market access.

 

Challenges that industry face:

  • New and more demanding regulatory requirements applying in the EU in 2020 and 2022 which increase the regulatory burden on the manufacturer and make it more difficult to take a product to market in EU countries.

  • Skilled and experienced regulatory and quality professionals are difficult to find.

  • Increasing business pressures to launch more innovative products under tight project timelines which requires innovative regulatory strategies.

  • Small start-ups often have minimal knowledge of what is required to meet quality and regulatory requirements.

How can CHIARA help address these problems? 

 

  • CHIARA can help navigate the new regulatory requirements and can assist with compliance in a timely, cost-effective and pragmatic manner ensuring continuity of supply.

  • Provide RA and QA support on a long term or interim basis while permanent headcount is identified.

  • Provide additional RA support to the client to ensure that project timelines are met.  Assist in the creation of innovative RA registration plans for new products.

  • Provide step by step guidance and hands-on support in meeting RA and QA requirements.

 

CHIARA offers a complete and cost-effective service with a clear breakdown of the necessary tasks in manageable portions and hands-on assistance in implementation of the tasks to ensure project success.  Working closely with you, CHIARA ensures staff buy in by adopting a collaborative approach.  Training is also provided if required to ensure that processes are understood and followed. I have demonstrated success in implementing Quality and Regulatory Plans, raising the RA QA bar while successfully ensuring buy-in of even the most reluctant of employees.

Benefits to the client of working with CHIARA

  • Implementation of a QMS appropriate for the size and nature of your business incorporating simple, workable and compliant procedures.  A collaborative approach is adopted to ensure you as the client buy-in to the processes.   

  • Training is provided during the project (if necessary) to ensure you are familiar with RA and QA requirements and your obligations.

  • Timely regulatory approvals for your products in accordance with the project timelines.  Requirement for all major markets will be considered to ensure there are no surprises during the registration process.

  • Cost-effective service by ensuring efficient delivery of projects to minimise consultant time as much as possible.  

  • A pragmatic risk-based approach to identify compliant and business-focused solutions to RA and QA problems.

  • A plan with clear goals and objectives coupled with a strong commitment and loyalty to see the project through from start to finish.   

Delivering with clarity – your partner in regulatory compliance.

Contact

✉  lesleypaice@chiara-raqa.com

☎ 07909 983 485

 

60 Constitution Street, Edinburgh, EH6 6RR

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