Life Scientific is a 'one-stop-shop' for all your off-patent plant protection product development and regulatory requirements
As 'chemistry for registration' specialists, we are uniquely positioned to secure 'fast-track' registration of established actives and formulations, where the role of chemistry is pivotal. Our unique coupling of chemistry and regulatory expertise allows for a seamless interface between applicant and regulatory authority, ensuring an accelerated registration process, getting products to market first, fast and without fail.
We’ve configured our business exclusively around this process, integrating expert teams of laboratory and regulatory professionals, and realising benefits of time and cost savings through knowing the key steps required – nothing more, nothing less - to get molecules to market fast.
This cradle to grave / holistic approach allows for a seamless interface between laboratory and regulatory authority, and thereby an optimised process. As development and regulatory specialists, we are uniquely positioned to accelerate new products to market.
Our goal is a simple one: to be the undisputed leader in off-patent plant protection product development.
Product Development and Registration: What we do
At Life Scientific, our team of development and regulatory experts offers the full range of product development capabilities, from formulation development to product registration. In our Good Manufacturing Practice (GMP) & Good Laboratory Practice (GLP) certified laboratories, the emphasis is on solution focused formulation and analytical development.
As 'chemistry for registration' specialists, we are uniquely positioned to secure 'fast-track' registration of established actives and formulations, where the role of chemistry is pivotal. Our unique coupling of chemistry and regulatory expertise allows for a seamless interface between applicant and regulatory authority, ensuring an accelerated registration process, getting products to market first, fast and without fail.
Our expertise includes:
Formulation Development
- EW, SC, CS, WDG, EC and seed treatment formulations
- Reverse engineering – qualitative and quantitative analysis of reference products, informed by formulation and regulatory scientists and sales and marketing
Analytical Development
- Forensic impurity profiling of technical materials
- Impurity identification using LC/MS/MS, NMR and high resolution MS
- Preparation and certification of impurity reference standards by synthetic or isolative processes
- Method validation for the determination of active ingredient and impurity content in technical materials and formulated products in accordance with SANCO/3030/99
- GLP 5-batch analysis
- Physical and chemical testing of formulated products
- Ambient and accelerated storage stability testing Efficacy
Efficacy
- Design and project management of comparability field trial programmes outsourced to localised test facilities
- Preparation of biological assessment dossiers
Safety/Toxicology
- All aspects of mammalian toxicity, environmental fate and behaviour, operator and consumer exposure and ecotoxicology
- Development of extrapolations, comparability/bridging scenarios and reasoned case arguments – guaranteeing accelerated market entry by levering the precedent
Dossier Preparation/Registration
- Regulatory strategy, project management and compilation of applications for national registrations throughout the EU
- Mutual recognition applications according to 91/414/EEC
- Experience with US and other international regulatory authorities through our partners
For more information, please contact our team at info@lifescientific.com