Strategic implementation.

We perform a personalised coaching to identify, analyse and integrate regulatory requirements considering business opportunities and clinical benefit that your product can bring.

 

Feasability study

Identify, analyse and plan the implementation of the best strategic scenarios in compliance with applicable regulation.

Overview

Through our coaching, you will find out the best strategy according the anticipated regulatory impacts of your clinical and business positioning.

You will identify short, medium and long-term alternatives.

Benefits

  • Increase in the proof of concept / effective development conversion rate.
  • Promotion of a structured approach for regulatory compliance with economic players.
  • Visibility on timeframe as well as organizational and financial efforts to be provided.

One Health Compliance expertise

  • Regulatory benchmarking and identification of clinical needs opportunities.
  • Analysis of strengths and weaknesses of possible scenarios for various markets (including EU, USA) and strategic recommendations.
  • Early communications with relevant regulatory bodies to identify their expectations and the impact on the compliance activities to be carried out.

Veterinary valuation

Extract the best of human health regulations to create and consolidate veterinary innovations.

Overview

We can support you to define the best practices in an unclear regulatory environment to promote veterinary scientific contribution both in animal health and in human health.

We provide a coaching to structure your strategy and to find solutions adapted to veterinary patients, veterinary healthcare professionals and the associated technical environment.

Benefits

  • Clarification of applicable regulatory requirements to be compliant with.
  • Promotion of the implemented approach to the healthcare professionals, the owners and to the medical device industry (human health).
  • Improve product development to strengthen its adoptability.

One Health Compliance expertise

  • Definition of the market, distribution, and organizational strategy to be deployed.
  • Identification and translation of applicable regulatory requirements for the target markets.
  • Support in product design and development activities.

Product and organization development

Optimize the implementation of regulatory requirements in your organization and for a better product development.

Overview

We will provide a specific coaching for a pragmatic implementation of regulatory requirements for product and organization development with the best cost/time/effort/product valuation ratio.

Benefits

  • Early requirements implementation.
  • Cost and deadlines control with an efficient structuring of activities to be adressed.
  • Securing the following regulatory milestones.

One Health Compliance expertise

  • Regulatory review of design and development data (clinical strategy, usability, risk analysis, standards and technical-regulatory specifications) and support for putting in place improvement or corrective actions.
  • Support in implementation of the quality approach, risk and information security management (incl. ISO 13485, ISO 14971, 21 CFR, ISO 27001).
  • Management of compliance activities.

Regulatory authorisations

Improve the quality of the regulatory dossiers and provide better communication with the competent bodies.

Overview

We help you detect discrepancies between data collected and the expectations of regulatory bodies and implement corrections.

We also support you for using good communication practices with the competent authorities.

Benefits

  • Improvement of scientific and technical/regulatory communication.
  • Identification of alternative solutions in case of lack of relevant data.
  • Decrease in deviation from initial approved deadlines.

One Health Compliance expertise

  • Gap analysis of your clinical and non-clinical data and help with corrections and improvement activities.
  • Drafting of regulatory dossiers (incl. technical documentation for CE marking and FDA pre sub, IDE, 510 (k)).
  • Support for response to questions from notified bodies and competent regulatory authorities during dossier reviews.

Change management

Ensure integration of regulatory changes, boost product and organization improvements.

Overview

We help you maintain your competitive advantage by anticipating and scheduling incoming regulatory requirements changes or new requirements related to an updated marketing scope.

We support you in responding to the evolution of the state of the art and integrating new user needs into the design of your products.

Benefits

  • Maintain products on the market.
  • Accelerated integration of product modifications.
  • Improvements in company practices.

One Health Compliance expertise

  • Impact analysis of the targeted change, associated regulatory activities and controls.
  • Audits of regulatory processes and implementation of improvement actions.
  • Regulatory access management for new targeted markets.
 

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