Snovi Group Regulatory Affairs and Pharmacovigilance Services for Pharmaceutical Products
Snovi Group provides regulatory affairs and pharmacovigilance (PV) services for pharmaceutical companies wanting to access the Latvian, Lithuanian, or Estonian markets.
The company’s wide range of regulatory affairs products includes assistance with marketing authorisation applications (MAA), as well as renewals, translation of product information and documentation required for registration, preparation of labelling, and proofreading.
Available PV offerings include data capturing and analysis, regular staff training, signal detection, and communication with regulatory authorities.
Snovi also supports clients with registration applications for drugs, dietary supplements, and cosmetics.
Regulatory affairs services to support drug registration
Snovi Group’s regulatory affairs team support pharmaceutical registration applications to the Baltic state markets. Customised consultancy serivces are offered to meet the requirements of each country, with any problems solved quickly and efficiently.
The company’s experienced regulatory managers help revise and prepare the necessary documents for registration, representing the client’s interests clearly and effectively. They also submit dossiers for the authorisation or renewal of national procedures (NP), mutual recognition procedures (MRP), and decentralised procedures (DCP).
In addition, Snovi Group prepares product information according to the latest quality review document (QRD), supporting label text approval and proofreading printed materials.
The company also represents manufacturers in the Latvian market for new product launches and PV system preparation, including marketing authorisation (MA) holder services.
Pharmacovigilance system maintenance
Snovi Group offers a large range of PV services. The firm’s experienced qualified persons for pharmacovigilance (QPPV) help establish an effective system.
The company also has access to the EudraVigilance database for the processing of individual case safety reports (ICSR) and submission of product information. Literature screening, staff training, preparation of local standard operating procedures (SOP), communication with authorities, and audit support are also available.
Snovi Group acts as a local safety contact, which includes signal detection, submission of periodic safety update reports (PSUR), and support on a national level within Latvia, Lithuania, or Estonia.
To help clients maintain adherence to new legislation, the company offers a number of in-house training and distance learning, including a good PV practice course.
Pharmacovigilance auditing services to meet regulatory requirements
Snovi Group’s PV auditing service ensures the company meets regulatory requirements through high-quality consultation and advice.
Its staff are experienced in PV, auditing, compliance, medical device vigilance, and ISO requirements.
The firm also helps develop corrective and preventative actions (CAPA).
Translation services for pharmaceutical documentation
Snovi Group offers a professional translation service for regulatory and PV documentation.
Available languages include English, Latvian, Lithuanian, Estonian, and Russian.
Artwork and text proofing for medical device and pharmaceutical product labels
Snovi Group creates mock-ups of clients’ artwork, labels, or patient information leaflets (PIL) prior to submission to regulatory agencies. These mock-ups can also be used to assess readability.
Pricing and reimbursing applications
Snovi Group helps clients prepare and submit price and reimbursement applications for pharmaceutical drugs and medical devices.
About Snovi Group
Snovi Group is experienced in good manufacturing practice (GMP), regulatory affairs, PV, and medical device best practice.
Its team ensures their knowledge is up-to-date through regular research and attendance of training sessions, including courses organised by the Latvian State Agency of Medicines, the European Medicines Agency, (EMA), the International Society of Pharmacovigilance (ISoP), and the Drug Information Association (DIA). This diligence ensures the company’s consultancy services are in line with current legislation.