Medicinal products
Medical products (also known as Pharmaceutical Products or Drug Products) referred to products used in medicine containing a substance or combination of substances that are intended to treat, prevent or diagnose a disease or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This product category is the largest group of products used in medicine and the main area of activity for pharmaceutical companies. The registration and marketing of medicinal products is strictly regulated by law, both at the European Union level (governed by EMA- European Medical Agency) and local (local, country-specific pharmaceutical law). According to European Directive 2001/83/EC, medical products are classified into separate types of application with different legal basis (MA categories), respectively:
- 8(3) Full or full-mixed application (complete dossier). Commonly known as ‘Original products’ including biotechnological drug products,
- Art. 10(1) Generic medicinal product application,
- Art. 10(3) Hybrid medicinal products application,
- Art .10(4) Similar biologic product application, so-called ‘biosimilar’ application
- Art. 10a) Well Established Use, WEU application (bibliographic)
- Art. 10b) Fixed Dose Combination (components already authorised separately), so called ‘FDC’ application
- Art. 10c) Informed consent application
- Art. 16a(1) Traditional Herbal Medicinal Products
Each of the application types has different registration requirements and requires a different Regulatory Affairs approach. In accordance with European law, medicinal products may be registered in specific types of procedures, including: Centralized Procedure (CP), National Procedure (NP), Mutual Recognition Procedure (MRP) and Decentralized Procedure (DCP). The choice of the registration procedure depends on the type of product and the MAH’s (Market Authorization Holder) commercial plans.
SciencePharma supports clients in all aspects related to medical products regulatory affairs including developing, manufacturing, registration and post-authorization services. We provide full regulatory affairs services for all drug registration categories as well as for all registration procedures.
Research and development
We offer consulting services in the field of assessing the potential of various projects development of medicinal products, devices or dietary supplements.
Preclinical and clinical development
SciencePharma is a leading, highly experienced consultancy company providing state-of-the-art services in a field of nonclinical and clinical studies.
Audits
Having broad experience in auditing of API manufacturers as well as of contract medicinal products facilities we offer independent GMP auditing services.
Regulatory Affairs
We offer multidisciplinary services in the field of Regulatory Affairs including support for pre-registration, registration and post-registration.
Pharmacovigilance
Pharmacovigilance is the process of monitoring the safety of medicines. Marketing Authorization Holders have a legal obligation to set up and maintain a Pharmacovigilance system.