Regulatory
Affairs

The field of RA encompasses all the work necessary to manage products’ registrations and to receive and maintain marketing authorization.
Choose PQE Group’s comprehensive support and broad strategic knowledge to launch products without delays and keep them on different worldwide markets.

Discover our solutions

Pharmaceuticals

Compile all the required informations for the amendment of the CTD dossier and stay ready for regulatory inspections targeting pharmacovigilance.

Medical Devices

Registrate and certificate MD and IVD products while collecting all intelligence on clinical evaluation, post-market surveillance and device vigilance.

Leverage regulatory strategy

To successfully comply with regulatory requirements and avoid penalties, rejects and delays, Life Science businesses need to be aware of the challenges posed by different laws operating in different market regions. Don’t risk losing quality and trust: choose the right training, guidance and support.

  • Manage products’ approval and registration
  • Speed up products’ launch
  • Reach different countries and assure global coverage
  • Keep products on the market consistently
  • Coach R&D to collect the right data from the first stages
  • Improve and standardize regulatory processes

Regulatory Solutions: a focus

A roadmap to EU MDR

PQE Group offers a specific regulatory support to any MD businesses looking to launch on the European market, needing guidance with CE Markings or wanting to ensure business continuity and renewal.
Book your first assessment with our team of experts and set up a time-tested strategic action plan to effectively and competitively manage regulatory compliance.

In-country Caretaker Service

To export products in Japan and handle Japanese regulatory procedures smoothly, foreign Life Sciences businesses are required to appoint an ICC (in-country caretaker) that will perform tasks concerning registration, review, GMP, translation and so on.
Thanks to our local experts and the broad presence of PQE locations across relevant market regions such as Japan, we can support you globally thinking locally.

Cannabis related regulatory standards

Many countries have already legalized the therapeutic use of Cannabis’ non-psychoactive varieties and many others are ready to follow this trend.
Read our article about the laws and regulations that apply to the medical cannabis market and be ready to follow these standards choosing PQE Group as your valuable and expert partner.

Why PQE?

To easily navigate the increasingly complex regulatory market and help our clients comply and sell their products in EU, US and Canada, LATAM, MENA, CIS, Africa and APAC, PQE Group relies on highly flexible and close multicultural teams of consultants expert in the laws and regulations operating in various countries.

Full Service Portfolio

Pharma Regulatory Affairs Full Service Portfolio

  • Worldwide Regulatory Strategy
  • Regulatory and Clinical Strategic Master Plans
  • Dossier Gap Analysis & Review for Drug Products and Drug Substances
  • DMF / ASMF / CEP Dossiers Preparation In eCTD or NeeS Format
  • Preparation of Product Registration Dossiers (Quality part)
  • Country-Specific Module 1
  • Experts Reports, Overviews and Summaries, and Investigational Medicinal Product Dossiers
  • Due diligences for the pre-clinical and clinical components of dossiers
  • Variation/Change Application Dossier
  • Reformatting of Documents to eCTD Compliant Submissions
  • Support for Regulatory Submission
  • Assistance in designing full development plans for NMEs or new indications/new formulations: 505(b)(1) and 505(b)(2) type submissions
  • Assessing IND, NDA (CTDs) and ANDA adequacy and completeness full support for registration in
  • Europe for MAA submitted according to all possible legal basis
  • Regulatory and Clinical Strategic Master Plans Experts Reports, Overviews and Summaries Briefing books for meetings with the FDA and EU authorities
  • Bioequivalence Study Designs and Dossier Review
  • Drug Development Training Support and assistance to FDA and EU authorities Meeting
  • Drug Listing
  • Regulatory Strategy for EU, USA, China, Mexico and other countries
  • Dossier preparation and submission in compliance with market requirements
  • EU MDR, IVDR Gap Analysis, Transition Strategy, and Readiness Assessment
  • CE Markings
  • 510(k)
  • US Agent service
  • Technical Documentation drafting, coaching and reviewing in compliance with device-specific guidance and Standards
  • Design Control compliance coaching
  • CEP/CER preparation, coaching and compliance review
  • Dossier Compliance Review and Gap Analysis
  • Person responsible for regulatory compliance for small-Company
  • Experts Reports, Overview, and Executive Summary Report
  • Prior Art analysis and Patentability Opinion
  • Freedom-to-Operate analysis and report
  • Patent Filling outsourcing support and liaison
  • Business Evaluation and Competitive Landscape analysis
  • Market Technology Assessment
  • Licensing Terms negotiation
  • Contracts revision
  • Partners search and selection
  • Company Internationalization and soft landing activities
  • Patent Valuation
  • Finished Products
  • Preliminary Formulation
  • Market Technology Assessment
  • Quality-By-Design Approach
  • Process/Technology Transfer & Scale-up
  • CMC & Regulatory documentation review
  • Projects review and Risk Assessment
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We will be more than happy to help you find the most suitable solution for your business.