Strategic Advice and Due Diligence
RPN helps to evaluate the feasibility of development and registration of medicinal products and Medical Devices within the proposed timelines and budget.
RPN also analyses portfolios of products and performs due diligence for in- and out-licensing.
Find below some details on the main services:
- Evaluation of the adherence to regulations and applicable guidelines for regulatory dossiers.
The evaluation is based on both scientific considerations and administrative aspects such as layout and presentation of the data, taking into account relevant current guidelines. This allows to start planning the activities needed to finalise the registration package at an early stage.
- Advice on registration strategy and health authority requirements:
- Evaluate technical data (chemistry/manufacturing, preclinical, clinical), to help determine the appropriate regulatory procedure and legal status for products
- Propose optimal filing and submission strategy
- Establish frequent contacts with regulatory authorities to facilitate compliance
- Liaison with the regulatory authorities:
- Assist in developing, assembling, reviewing the meeting request package and initiate contact with agencies on client’s behalf
- Attend meeting with authorities
- Comprehensive support for Due Diligence in mergers and acquisitions for all regulatory matters:
- Regulatory due diligence and preparation of due diligence report
- Audit manufacturing operations, resources and quality systems to ensure adequacy with applicable regulatory requirements (GMP, GCP, GLP, GVP; ISO, and specific national requirements)
- Evaluate the regulatory feasibility of developing and commercializing the products in the target markets
- Position the products with reference to competitors
- Analyse and evaluate regulatory and reimbursement strategy
- Anticipate the impact of changes in the Regulatory and Market Access environments on product portfolios
Facilitation of local concerns via a network of partners in EU countries and USA
Consolidated network of partners in EU countries and a local Agent in the USA allow us to support our clients facing specific local issues.