Countries: SLO, CRO, B&H, SRB, FYR Macedonia
We have a team of Regulatory Affairs professionals with extensive experience across the full range of regulatory procedures and highly skilled in interfacing with Regulatory Agencies in all countries where we operate. We ensure high quality, compliance with regulatory requirements and on time delivery.
Our activities include:
• Regulatory services
- Regulatory service for Centralised Procedures (CP), Decentralised Procedures (DCP), Mutual Recognition Procedures (MRP), National Procedures (NP) and nCADREAC (Croatia)
- Advice on submission strategy
- Submission of Marketing Authorisation Applications (MAA) for:
- Innovative and generic pharmaceuticals (including biotech)
- OTC
- Vaccines
- Herbal and homeopathic medicinal products
- Radiopharmaceuticals
- Blood-based products - Registration of:
- Medical devices
- Food supplements
- Cosmetics - Post submission support (answers on Letters of Deficiency, fulfilment of the documentation)
- Post approval support including preparation, submission and management of variation applications, line extensions, renewals and notifications
- Preparation of product information in accordance with Slovenian, Croatian, B&H, Serbian and Macedonian medicinal product and medicinal device legislation (SmPC PIL, labelling)
- Readability testing
- Preparation of non-clinical and clinical overviews and summaries
- Preparation of marketing authorization application dossiers in the European CTD format: reformation of existing pharmaceutical documentations from NtA (Notice To Applicants) to CTD ("Common Technical Document") format
- Mock-ups preparation
• Pharmacovigilance services
- Advice on PV systems
- Development and implementation of PV system
- Regular literature searches
- Electronic or Paper based Reporting to EMEA and European Competent Authorities
- Preparation of Periodic Safety Update Reports, Summary Bridging Reports and Addendum Reports,
- Providing Qualified Person for Pharmacovigilance (QPPV)
- Providing Local Qualified Person/Representatives
• Clinical trials services
- Advice on clinical trial application requirements
- Preparation and management of clinical trial applications to Competent Authorities
- Procurement of local clinical trial insurance
- Obtaining import licenses for investigational products, ancillary supplies and equipment acquiring export licenses for biological samples and re-export licenses for returnable equipment
• Other services
- Translations and back-translations into multiple languages
- Legal Representative Services
- We can organize GMP-certified drug storage facilities
- Consultancy in advanced drug development projects, marketing authorisation strategies and procedures
You need to upgrade your Flash Player
Copyright (c) Clines Farmacija d.d., 2008. All rights reserved. | Impressum | Sitemap