Client Case Study

Tackling each project related to regulatory with passion and determination, we’ve been working hard to turn heads for our clients. Here are a few of our projects that not only deliver great customer experiences but have driven measurable results.

Who we are engaged with: 

Director

Our Approach:

Understanding the plant size, production volumes and other several factors that are required for gaining a complete understanding of the client requirement

To set up a complete manufacture plant there is the need for

  • Layout Design of plant
  • Clean room guidance for regulations,
  • Equipment and Utility Validation,
  • QMS and Certification.
    1. Training the staff as per each SOP
    2. On-Site implementation of the System.
  • Indian FDA Manufacturing license

Challenges or Requirements:

The client wanted a consultant to handle the complete manufacturing unit for Orthopaedic Implants. Which must meet the Local and international regulatory norms.

We have created the layouts, conceptualize the clean room for regulatory aspects, prepared the validation documentation and establish the Quality management system. With this, we applied for manufacturing license and the joint inspection by the CDSCO and State FDA was doing.

Results or Deliverables:

  • Design and development for the complete Orthopedic manufacturing unit.
  • Clean Room Design.
  • Process Validation
  • Certification and QMS
  • FDA and CDSCO.

Who we are engaged with:

Owner

Challenges or Requirements:

The client wanted an expert to handle USFDA audit and also to look at the facility and documentation. (describe USFDA audit)

Our Approach:

We provided guidance on how to apply for the approval after launching the product. We reviewed the facility and documents, and it indeed required a revamping of the facility, validations, QMS documentation and training had to be provided. We revamped the facility, documentation, training adhering to the regulatory expectations and adequate justifications for the changes. Also, helped with the inspection of USFDA.

Results or Deliverables:

  • USFDA audit,
  • Facility layout,
  • Process validations,
  • QMS documentation,
  • Training.

Who we are engaged with:

QA Head

Our Approach:

We help our client with complete manufacturing unit set up including facility layout design, installation, documentation and audit. We assist for the Manufacturing license and after that, we help them to market their product in the European Economic Area with approval for CE Marking.

Results or Deliverables:

  • Facility layout design
  • Guidance for Installation
  • Process Validation
  • Audit (need data)
  • QMS and Certification like CE marking.

Challenges or Requirements:

The client wanted a consultant who provides guidance for manufacturing unit. The complete manufacturing unit includes Facility Layout Design, Process validation and regulatory QMS & certifications.