Regulatory Affairs

A full service provider supporting companies through the entire regulatory lifecycle.

Regulatory & Clinical Strategic Services

PQE supports customers through both the entire drug and medical devices regulatory lifecycles, providing a full range of regulatory activities.
Our service begins with the development of the regulatory strategy and concludes with the editing, amendment and submission of the necessary documents of the dossier. Due to the expertise of our consultants, fully electronic submissions for the EU / USA / Canada, along with paper submissions are handled in the fastest and most professional manner, while ensuring that dossiers are compliant to the strictest regulations.

Pharma Capabilities
  • 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
Medical Devices Capabilities
  • Regulatory Strategy for EU, USA, China, Mexico and other countries
  • Countries Submission Dossier preparation in compliance with market requirements
  • EU MDR, IVDR Gap Analysis, Transition Strategy, and Readiness Assessment
  • Technical Documentation drafting, coaching, and review 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

Clinical Trial Services (GCP Compliance)

The development of a GCP Quality Management System (plan and resources) is the basis to promote and support compliance, while minimizing regulatory risk.
PQE proposes the implementation of a GCP quality strategy, tailored to the Client’s requirements, and supports an effective and compliant conduction of clinical trials, based on the practice of the most innovative Quality by Design and Quality Risk Management approaches.
PQE emphasizes good quality control, with adequate documentation throughout the delivery of clinical trial data by the investigators and throughout all data management process, leading to a regulatory submission.

Pharma Capabilities
  • Auditing service (e.g. Initial, Follow-up, For Cause… i.e. CROs qualification, Investigational Sites, Centralized Laboratories)
  • SOPs/Policies Development, Issuing and Review
  • Study Protocol, ICF, IB and other Essential Documents Review
  • TMF and ISF review and quality check
  • GAP analysis of the quality System vs new EU-CT regulation and ICH E6 R2
  • Data Integrity and Compliance Assessments
  • Clinical Process mapping
  • Training (From basic GCP to advanced specific trainings)
  • E-Learning content development
  • Training on the job (i.e. Audit with Junior Auditors and CRA)
  • Computer System Validation (i.e. eCRF, eSD, eTMF, Patient Database, IV/WRS…), Data Migration plan and Data Quality Control
  • Inspection Readiness and Support (Sponsor, CRO, Investigational Site, Back & War Room)
  • CAPA definition and implementation
  • Archiving Requirements for Study Documents
  • Bioequivalence Study Design
  • Clinical Study Setup
  • QA Services & Training
  • Compliance Verification with minimal technical requirements for clinical sites involved in Bioequivalence studies (Determina AIFA n.809-2015)
  • Risk Management
  • Vendors – CRO Selection

Pharmacovigilance (PhV Compliance)

In 2010, Regulatory Authorities raised the bar of compliance of the Pharmacovigilance System and an increasing number of countries are now performing routine regulatory inspections targeting Pharmacovigilance.
An established quality system that is adequate and effective for performing pharmacovigilance activities has become a regulatory requirement. PQE can support the implementation of a pharmacovigilance quality system, starting from the compliance assessment of “AS-IS” scenario, which involves document editing and the quality system deployment at corporate or local level. The focus of PQE’s support is the compliance with applicable regulation as well as the suitability of the system to the company needs.

Pharma Capabilities
  • Auditing service (qualification of suppliers and over-sight on MAHs, Affiliates and specific audit to data and/or documents, internal Audit)
  • PV Quality Assurance Outsourcing and EU-QPPV Outsourcing
  • SOPs/Policies Development Issuing and Review
  • CAPA definition and implementation
  • PSMF, SDEA, PSUR, DSUR, Paper Based Audit and other PV documents review
  • Data Integrity and Compliance Assessments
  • Pharmacovigilance Processes Mapping
  • E-Learning Content development
  • Gap Analysis of the Quality System vs EU GVP
  • Computer System Validation (i.e. Argus Safety, ArisG AERS, PcV Manager, SafetyDrug… in-house and on-demand versions) Data Migration plan and Data Quality Control
  • Remote Data Entry support
  • Risk Management Plan review

Drug Development & CMC (Chemistry Manufacturing Control)

The Department of Drug Development supports companies in the assessment and commercial exploitation of their projects, from basic research to preclinical development. We work with our clients to develop successful strategic partnerships, improve market and distribution strategies, and evaluate licensing deals. We also leverage our international network in searching for the perfect commercial partner(s) for our clients’ innovative technologies. With a knowledge-driven approach and global network, we can offer an objective perspective in evaluating existing projects, business and new ventures.

Drug Development Services
  • 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
CMC Services
  • 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