Overview

Emphasizing more on the risk assessment approaches for cross contamination (VICH GL 18, ICH Q3C) of one drug to another in shared manufacturing facilities, the European Medicines Agency (EMA) has released a new set of Good Manufacturing Practice (GMP) guidelines to calculate health-based exposure limits in Active Pharmaceutical Ingredients (APIs) and intend to cover safety for human and veterinary medicinal products. Using non-clinical study end points such as no-observed-adverse-effect level (NOAEL) / lowest observed adverse effect level (LOAEL) and the appropriate uncertainty factors (UFs), the health based exposure limit-Permissible Daily Exposure (PDE) value is calculated. With the EMA’s GMP guidelines already put into practice starting Nov 2015, manufacturers of drug products may face certain procedural complexities such as:

  • Establishment of PDE value and monitoring the levels of the cleaning validation for a huge set of medicinal products from various shared facilities
  • Access to the toxicological literature along with the expertise in risk assessment, which is required to derive a PDE value
  • High-level understanding of risk assessment for residual active pharmaceutical ingredients (APIs) / substances for streamlined data collection to be incorporated into PDE reporting requirements

With an industry-proven expertise in decoding and implementing various time-critical health authority mandates, Freyr’s health-based risk assessment team assists manufacturers of drug products to carry over cross contamination assessments and prepare audit-ready PDE reports. 

 

Freyr Capabilities

  • End-to-end health based risk assessment
  • Expertise in calculating and implementing PDE in cleaning validation processes
  • Access to professional databases and required tools for exhaustive literature search and prediction of toxicity based on (Q)SAR
  • On-time and compliant document deliverability 
 

Freyr Advantages

  • Qualified, trained and experienced data scientists and toxicologists
  • In case of scarce toxicological data / literature and absence of NOAEL value we use read-across data from surrogate compound or use (Q)SAR data as applicable to arrive at feasible PDE value
  • Well-maintained archival of the background information and literature, which helps in supporting regulatory queries, if any
  • Case-by-case consideration for medicinal products: manufacturing conditions, manufacturing requirements, route of administration in target patients, etc. to appropriately calculate the final PDE value
  • Audit-ready and highly professional dossier preparation
 

EMA Compliant Health Based Risk Assessment (PDE)

Freyr has performed toxicological gap analysis and streamlined 50 PDE value evaluations for established medicinal products Download

CLIENT TESTIMONIALS

 
  • During the past several years, I’ve had the pleasure of working with Freyr in the publication, validation and electronic submission of regulatory documentation to the US FDA. The Freyr team has provided excellent professional service. The staff is knowledgeable, responsive, and offers fast turn-around and accurate e-publication services at a reasonable cost. I have no hesitation in recommending them to my clients.

    President,
    An Independent regulatory and quality consulting company

  • Freyr was a great find indeed. The Freyr Publishing team catered excellent Study Report publishing services. The icing on the cake was their proper coordination, flexibility, dedicated study team, timely and constant communication and subject matter expertise that added to the ease of doing business and towards successfully accomplishing the end goal. This, as well as the fair pricing, is what sets Freyr apart from their competitors. As always, I would recommend Freyr again with no hesitation and should the opportunity arise, we absolutely approach Freyr.

    Project Manager,
    A full-service Clinical Research Organization (CRO)
    Based in Florida

  • We are making great progress and we are impressed with Freyr’s commitment to success and willingness to be flexible; you clearly have capable and experienced people in your organization.

    – VP and Head of Regulatory Operations of a Global Top 5 Pharma & Consumer Company

  • We would like to congratulate Freyr team for their excellent service and error free XEVPRM submission with short notice and well within the regulatory timeframe. We sincerely appreciate their technical skills and their extraordinary and selfless effort.

    We are pleased to acknowledge the timely support and recommend Freyr to everyone who are looking for such services.

    – Vice President, Clinical Research & Pharmacovigilance, Microlabs

  • It has been an absolute pleasure working with Freyr over the past few months. Thank you very much for all the hard work – I could not imagine how difficult it would have been without the team being so proactive and diligent.

    I look forward to returning to work with you in January and an exciting new chapter in our time.

    – GRA Operations Program Manager, Top 5 Global Pharmaceutical Company

  • We have made great progress in a short duration and are impressed with the 162 positive acknowledgements from EMA for the XEVMPD submission project.

    I would like to thank the entire team for their support for critical XEVMPD compliance activities.

    Program Manager, Global Top 5 Pharma and Consumer Health Company

  • I would like to thank the Freyr team for all the support they have provided. The Ops team is very satisfied with the level and quality of services from all the resources that we have on board.

    Thanks to their commitment and discipline, we were able to deliver on all key objectives that had been outlined for us in 2014.

    - Head of Regulatory Operations, Top 5 Global Pharmaceutical Company

  • As we near the completion of a major filing, I would like to thank Freyr and recognize the team resource’s performance. It has been a great addition to our team and throughout all the projects, the involvement has been impeccable, illustrating not only professional demeanor, but in-depth skills, dedication, attention to details, willingness to switch gears and deliver timely results.

    We recognize and acknowledge the exemplary performance and look forward to working together.

    – Manager, Regulatory Operations, Global Top 20, $20+ Bn,
    Pharmaceutical Company

  • Great company for eCTD and regulatory supporting is Freyr. I am approaching the end of our first year engagement and we are extremely satisfied with the quality of their resources and leadership. They also have their own suite of tools for publishing eCTD and from what I have seen they offer a very viable publishing solution.

    - Associate Director, Regulatory Technology and Ops,
    Global Top 20 Pharmaceutical Company