Regulatory Affairs

ExperTrials offers strategic regulatory advice and hands-on outsourcing solutions to biotech and generic companies through the entire lifecycle of their products (medicines and medical devices).

We provide flexible solutions to meet your company’s needs from product development, registration through to launch:

Clinical Trial Application (CTA)

We are able to perform such service in other worldwide markets such as the United States of America, Canada, Australia, Israel and Japan.

ExperTrials’ Head of Regulatory Affairs will coordinate all our country Clinical Research Consultants (CRC) who will be responsible for Regulatory activities in their respective country. As our CRCs are locals, you can rely on their awareness of the applicable regulations in each region/country.
Our CRCs have strong experience in regulatory affairs activities related to clinical trial applications procedures for both drugs and medical devices.

Expertrials services

  • Consultation on legislation and country-specific requirements
  • Support with regulatory strategies
  • Preparing and filing CTAs for drug or medical device
  • Multi-country submissions and effective follow-up to Competent Authorities and Ethic Committees
  • Substantial and non-substantial amendments throughout the clinical trials
  • Management of clinical trial agreements with sites (hospital contracts)

Marketing Authorization Application (MAA)

We also accompany and support you in the last step and most exciting part of your drug development: the marketing authorization of your drug or medical device.

In Europe, our regulatory experts submit MAA by notifying EMA at least 7 months before the submission by following one of the procedures below:

Expertrials services

  • Legal representation as Marketing Authorization Holder (MAH) for the medicinal product manufacturers, who do not have establishments in EEA,
  • Advice on registration strategy: legal basis and selection of registration route,
  • Management of European registration procedures (CP, DCP, MRP, National)
  • Payment of fees to EMA,
  • Provide a project plan and timeline,
  • Pre-submission administrative activities, DCP Slot booking (if more than one country), National filing (if one country), Request the country to act as RMS (liaise with RMS in case of DCP filing),
  • Advice for appointment / consultation of Qualified Person (QP) for quality and Qualified Person for Pharmacovigilance (QPPV), (if Applicant Office is not in EEA and do not have their own QP and QPPV)
  • Coordination of the preparation of the Customer’s MAA following eCTD submission
  • Prepare in collaboration with MAH, responses to HA queries.
  • submission of the electronic Common Technical Document (eCTD)

Generic Application

As for all medicines, generic medicines must obtain a MA before they can be marketed.

The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). A generic medicine is developed to be the same as a medicine that has already been authorized, called the reference medicine.

As FDA and EMA recommendations are to provide new methods to identify and eliminate unnecessary in vivo BE studies.

“WHO’s guidance” gives the following definition for biowaiver: « The term biowaiver is applied to a regulatory drug approval process when the dossier (application) is approved based on evidence of equivalence other than in vivo bioequivalence test. » In other words, biowaiver means an exemption for time consuming and expensive in vivo bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution.

By applying biowaiver approaches whenever possible, generic companies can save a lot of resources.

Expertrials services

  • Legal representation as MAH for the medicinal product manufacturers, who do not have establishments in EEA,
  • Assessment of eligibility of biowaiver based on BCS (BCS biowaiver) with the involvement of our pre-clinical CRO preferred partner in the realization bioequivalent (BE) / bioavailability (BA) tests (solubility and permeability) against reference product,
  • If definition of BCS biowaiver is fulfilled, ExperTrials prepares the MAA dossier following eCTD submission (see MAA section above).

Paediatric Investigational Plan (PIP)

A paediatric investigation plan (PIP) is a development plan intended to support the authorisation of a medicine for children. It aims to ensure that the necessary data is obtained through studies in children, when it is safe to do so.

Pharmaceutical companies are required to perform clinical studies in children before being able to apply for marketing authorization of a new medicinal product in the EU (or for a new indication, dosage form or route of administration of an authorized, patented product), unless they have agreed a waiver or a deferral with the Paediatric Committee (PDCO) of the European Medicines Agency (EMA).

Expertrials services

  • Advise as to whether a deferral or waiver may be appropriate,
  • Complete preparation of PIP application in the EU or US.

Orphan Drug Designation (ODD)

A status assigned to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market. 

Expertrials services

  • Determine if your product is eligible for ODD,
  • Provide the necessary support for your application to both the EMA and the FDA.
Get in touch with us and let’s start your project !

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