International Regulatory Affairs

Experience and Organization

Working closely with Dr. Regenold GmbH and Regulanet®, a worldwide network of regulatory affairs experts with hundreds of  members in over 90 countries, Pierrel Research provides national and international high quality and unique regulatory services and solutions to life science companies, helping them to understand and manage the complexity of the different regulatory requirements, bring their products effectively to market and maximise the value of their asset.

Product Categories

We have expertise in the following product categories and the respective industries:
Prescription reimbursed medicines (Rx) including orphan drugs:

  • Over The Counter medicines (OTC)
  • Generics, including niche generics
  • Medical Devices and Medtech Applications
  • Biotechnology derived products
  • Herbals
  • Food Supplements/Nutracueticals
  • Cosmetics and Cosmeceuticals
  • Biocides
  • Veterinary

Strategy Management of Products Development

  • Provide regulatory advice in the early phases of development projects
  • Define the product concept
  • Interpret regulations and guidelines
  • Develop strategies for technical aspects of development (quality, preclinical and clinical)
  • Design, conduct and report Clinical Trials
  • Determine market access requirements and develop a strategy in the early phases
  • Pro-actively interface with regulatory bodies to consider their scientific advice (study protocol assistance)
  • Recommend and advise clients on legal classification
  • Propose optimal filing and submission strategies

Marketing Authorization Application

  • Dossier preparation (CTD, eCTD)
    • Module 2.3, 2.4, 2.5, 2.6, 2.7
    • Module 3
  • Translation Services
  • Pre-submission meetings
  • Submission and follow-up including reply to authorities concerns and filing approvals

Market Access

  • By gaining an understanding of client’s commercial needs, the key decision makers and route to market, we are able to recommend regulatory and market access solutions, to help our clients bring their products effectively to market and maximise value from their asset.
  • Consequently we lead, facilitate and provide support to clients in the following areas, involving specialists where necessary:
    • Regulatory landscap
    • Pricing and reimbursement, including, for prescription drugs and medical devices, the requirements of the payers and key decision makers

Portfolio Analysis and Life Cycle Management

  • Portfolio and business strategy
  • Portfolio analysis and management, including process implementation
  • Product portfolio completion via licensing in/out and partnering/gap filling
  • Product launch facilitation
  • Post launch life-cycle management
  • Supply Chain Management
  • Sourcing
  • Costs
  • Logistics
  • Product/Technology Transfer and its processes