Overview

Are you compliant? This is one question which companies are generally afraid to answer. The current trend is moving towards a worldwide harmonization of Quality/Safety/Customer requirements for Biotechnology/Pharmaceutical, and Medical Devices. We can help you in this effort. The Pharmaceutical, Biotechnology, Genomics, Chemical, and Medical Device supply chains are spreading into the developed and emerging markets, so it requires organizations to comply with stringent yet obligatory Quality, Safety, and Regulatory requirements in each geography where your products are distributed. Whether you are a manufacturer or a supplier to the Pharmaceutical/Medical Device/Biotechnology Industry, your business expansion and levels of customer satisfaction (and Continual Process Improvements for ISO9001 Quality Management Systems) rests principally on you.

Assisting you in your development of GCP (Good Clinical Practice), GDP (Good Distribution Practice), GMP (Good Manufacturing Practice), and compliance to all other applicable national and International Regulatory requirements, such as ENISO13585 compliant Quality Management Systems, the European Medical Device Directives/CE Marking, and Health Canada requirements, as examples is our expertise. At Freyr, we have the capability to assist you in the design, development, implementation, and integration of all your Regulatory and Quality needs on a worldwide platform. We are experts at integration of business needs with your regulatory needs. We will evaluate your requirement and suggest inputs to the business processes that are designed to assure customer satisfaction, and regulatory compliance. We make sure that all your processes and products are aligned with the compliance requirements such as FDA/13485/9001, FDA 483s, etc. and other geo-specific compliance standards. With our audit readiness strategies, we help you recognize the existing gaps in the process and suggest corrective and preventive actions to get compliant. Our team has extensive domain understanding and hands-on experience on execution of industry compliance requirements.

 

Freyr Capabilities

Training Services

  • ICH-Good Clinical Practices E6
  • End to end training process, training process automation, training system validation
  • GDP (Good Distribution Practices), GAMP (Good Automated Manufacturing Practice)
  • Process training for Pre-clinical phases and all stages of clinical trials
  • ERES (Electronic Record/Electronic Signature)

Validation Services

For Large Projects
  • Audit and Compliance | Validation
  • CSV (Computer System Validation)
  • End to end product and interface validation
  • Product validation in Healthcare and Life sciences
  • Retrospective validation
  • Process consulting and training for SDLC (Systems Development Life Cycle) waterfall &sprint methodologies
  • Product Quality Management
For Small Projects
  • GxP assessment, ERES (Electronic Record/Electronic Signature) assessment
  • 21 CFR (Code of Federal Regulations) Part 11 assessment, EU Annex 11
  • CSV (Computer System Validation), Audit trail adequacy assessment
  • BCM (Business Continuity Management) & DR (Disaster Recovery) adequacy assessment

Audit & Compliance Services

  • Process architecture by integration of multiple management systems (ISO 9001, ISO 27001 with CMM and USFDA, EMEA, MHLW)
  • Integration and management of processes & systems post acquisitions and mergers of the companies
  • Audit support  (USFDA, MHRA, MHLW) for SDLC – SaaS model and On-premise model
  • Audit support for all cloud application services
  • Gap analysis, training, audit support for HIPAA privacy, security and omnibus – SaaS model, On-premise model and cloud application services
  • GLP, esoteric testing and BA-BE analytical process set-up, gap analysis and audit support for ISO 17025, ISO 15189 and CAP accreditation standards
  • Auditing suppliers (Customer’s supplier)
  • GxP Audits
  • Data center audit
  • Data archive facilities (Paper and e-archives) audit
  • SEZ unit IT/ITeS/BPO infrastructure audit for healthcare and Life Sciences business suitability
 

Advantages

Freyr intends to provide you a competitive lead by assisting you plan, create, and control manufacturing facilities. With our expertise, you can be profited in following aspects:

  • Integrated Process Model
  • Maintain Brand Image
  • Overall Cost Savings
  • Implement Effective and Compliant Business Processes
  • Establishing Validation and Qualification Strategies

CLIENT TESTIMONIALS

 

  • I approached Freyr with an issue we were having in quickly confirming the global acceptability of several new raw materials for use in our products. Within a few days, their team provided me with a comprehensive review by country citing regulatory references. The reports also included valuable additional information regarding cosmetic uses of the materials in various markets. For a very reasonable price, Freyr was able to provide our company with exactly what we were looking for.

    – Director, Regulatory Affairs, US based, Cosmetics Manufacturing Company

  • Freyr provided assistance and the review was conducted thoroughly and rapidly. I also appreciate that the team called me this morning and walk me through the files. It is once again a pleasure working with Freyr.

    Just wanted to say that the team are doing a great job. Please keep up the excellent work!

    – Product Specialist Global Regulatory Affairs, Global Top 5 Healthcare Company