Product development

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.

Regulatory Services

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

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.

Pharmacovigilance

Qualified team manages ADR’s, follow-up products safety and literature review. Preparation of PSMF, RMP, PSURs are within our capabilities.