APC’s team of experts and national consultants can help you with the preparation and submission of dossiers, and help you to navigate the rapidly changing EU guidance and data requirements.
APC provides complete regulatory services for the support of both new and existing active substances:
- Assessment of registrability for new and existing active substances; including review of the existing data packages against current requirements
- Pre-submission meeting support
- Data gap analysis
- Preliminary risk assessments
- Commissioning and monitoring regulatory studies and field trials using an independent selection of CROs
- Preparation of OECD study summaries, CLH reports, MRL and CLP dossiers
- Preparation of Updating Statements and Supplementary dossiers
- Literature reviews
- Preparing higher-tier approaches, including reasoned arguments and data waivers where appropriate
- Provision of expert responses for Commenting and Reporting Tables
- Liaising with the European Commission, EFSA and EU Member States
- Task Force Management
APC has supported a range of different active substances through the previous EU review programme, and continues to provide support to our clients through the Annex I Renewal programme (AIR2, AIR3 etc.). More information on Annex 1 Renewal
APC can prepare and submit product dossiers for new and existing products.
On behalf of our clients, APC has successfully submitted zonal applications in the Northern, Central and Southern Zones, together with national addenda/applications for the majority of EU Member States.
From the outset APC can provide strategic advice in identifying and communicating with the RMS/zRMS including pre-submission meeting support.
We are highly experienced in writing comprehensive study summaries, conducting risk assessments according to EU and national requirements, and preparing higher tier approaches including reasoned cases and data waivers where appropriate.
We have an extensive network of national consultants throughout Europe, who work in collaboration with our technical teams based in our EU offices (UK, France, Poland and the Czech Republic) to provide our clients with regulatory advice and support.
Our consultants can prepare labels and Material Safety Data Sheets (MSDS) in the local language to comply with national requirements. By having local experts in a wide range of EU Member States, we can assist you at each step of the submission process.
For further information, please contact either Chris O’Hara or Lesley Young (email@example.com)