Nassington Limited operates providing services to fit all your needs, in Product development, Regulatory affairs, Clinical trials and Pharmacovigilance.
Nassington Limited is a pharmaceutical company, with experience of 30 years that design, develop, register and supply specialized pharmaceuticals with innovative formulas and added value characteristics.
Our pharmaceutical products have been registered:
Our research activity is aimed at the development of generics, hybrids, well established pharmaceutical products, offering high marketing potential.
At the end of 2019 the number of our registrations and marketing authorizations totaled up to 30.
Nassington Limited is an organization, which can support pharma companies through scientific advice, formulation development, API qualification and testing, patent and IP coverage analytical method development and validation, scale-up and technology transfer, formula and process optimization, scale up and method transfer, GMP and QP services, dossier compilation and publishing, submission management with agencies, commercial manufacturing and life cycle management.
Our Regulatory team has a big experience in order to support pharmaceutical companies to comply with the European pharmaceutical legislation needs and to approve a product through health authorities by providing all the pharmaceutical parts of the files needed.
Our experience allows the selection of best regulatory strategy from all existing possibilities. We provide support for all types of regulatory procedures using electronic submission of regulatory data (e-CTD). Also, we can support Pricing and Reimbursement strategy as long as the readability testing, bridging statements and reports.
Clinical trials department can organize and conducting clinical trials and bioequivalence studies. Our team works with a first-class network of validated clinical research organizations (CROs) to provide expert experience, skills and knowledge to take pharmaceutical products from concept through to distribution. We can manage PK/PD studies, Bioequivalence/bioavailability studies, Clinical efficacy studies, Expert report writing.
Qualified team manages ADR’s, follow-up products safety and literature review. Preparation of PSMF, RMP, PSURs are within our capabilities.