Staphyt regulatory affairs: Local players

Regions of registration

Local actors for each region

Staphyt’s regulatory teams are located in EU countries, Great Britain and Brazil. Beyond its network of locations, Staphyt relies on a solid network of partner consultants to support its clients in all regulatory procedures.
Our clients thus benefit from language skills, local experience, as well as solid relationships with the relevant regulatory authorities.

Succeed in your product registration in Europe

Staphyt’s European regulatory teams are able to provide comprehensive technical expertise, multiple language skills, and in-depth regulatory knowledge across all of Europe on all types of products and substances. We prepare complete dossiers to meet the requirements of each country and we are able to submit them directly on your behalf to the regulatory authorities. If necessary, we ensure the follow-up of your applications after submission.

European regulations in force

Plant Protection Products Regulation (PPPR) (EC) No.1107/2009
Biocidal Products Regulation (BPR) (EU) No. 528/2012
Registration Evaluation Authorisation and Restriction of Chemicals (REACH) (EC) Reg. No.1907/2006
Fertilising Products Regulation (FPR) (EU) No. 2019/1009 and Regulation (EC) No.2003/2003

Transparent, agile, and productive processes for your registration in Brazil and Latin America

Our regulatory team is based in Sao Paulo (Brazil) and is in direct contact with regulatory agencies and supports companies based in Brazil or elsewhere.
Our experience is essential to meet the regulation requirements of the phytopharmaceutical and fertilizer industries. We work with all types of products, whether it’s chemicals (TGAI, formulated products, mixtures, etc.), semiochemicals, biologicals, biocides or adjuvants.
With the support of a network of partners in Latin America, we prepare complete dossiers to meet the requirements of each country.

Regulations in force in Brazil

PPP Plant Protection Products Regulation – Law 7. 802 (11/07/1989) regulated by the Decree 4.074 (04/01/2002)
Fertilisers Regulation – Decree 4.954 (14/01/2004)
Biocidal Products Regulation – Resolution 59 (17/12/2010)

List of services at Staphyt Brazil

Strategic regulatory consultancy for a successful route to market of your product in Brazil
Dossier preparation, submission and post submission support to regulatory agencies in Brazil (MAPA, ANVISA and IBAMA) and other countries in South America
Monitoring and follow-up of registration processes with regulatory agencies
State register
Field efficacy, laboratory and residues studies: managing CROs to generate the data, defining the protocol, study monitoring, reviewing of reports and approval of the final report, according to GLP standards
Technical review of laboratory studies that are part of the registration process package (physical-chemical, toxicological and ecotoxicological)
Technical guidance for responding to government requirements for ongoing registration processes
Import permits for experimental products (RET/EUP) and registration hold

Strong network for international registration

We provide cost-effective regulatory solutions and outstanding client care in over 40 countries worldwide.
The expertise of our in-house team is supplemented by a network of external partners providing agronomic, regulatory and scientific knowledge as well as established relationships with the associated regulatory bodies, local distributors, CRO’s, universities and research institutes.

Our services, through our network of external partners, include

Regulatory & product development advice at country level
Expert negotiation with local registration authorities
Advice on selection of local distributors
Cost effective Data Gap Analysis to select the optimum route to registration
A dedicated focal point and project management service for all clients
Placement & monitoring of field trials & regulatory studies
Regulatory advice for establishment of import MRL’s (tolerances)
Preparation, submission & follow-up of registration packages
Local permit applications, documentation or certificates preparation and legalisation
GHS classification for SDS and product label hazard communication and design