FarmaliRA Consulting is an independent consultancy offering Regulatory Affairs, Quality Assurance and Pharmacovigilance services for pharmaceutical companies (human, veterinary and herbal).
• FarmaliRA Consulting assists you in preparing submission of your Marketing Authorisation Application (MAA) and achieving approval quickly and efficiently.
Once approval has been obtained, there is usually a need for variations. For example, introducing process scale-up of production, changing details in the product characteristics, introducing new manufacturing facilities, introducing a new API (Active Pharmaceutical Ingredient) manufacturer, extending the shelf life and so forth.
• FarmaliRA Consulting assists you in preparing the submission of variations on your Marketing Authorisation (MA) and achieving approval quickly and efficiently.
Many pharmaceutical companies are changing the location of their manufacturing sites, mostly to India and China. There is a considerable increase in the EU Qualified Person’s task to release the imported finish products to the EU countries.
• FarmaliRA Consulting assists you by acting as the EU QP of your company.
• FarmaliRA Consulting assists you in preparing submission of your Marketing Authorisation Application (MAA) and achieving approval quickly and efficiently.
Once approval has been obtained, there is usually a need for variations. For example, introducing process scale-up of production, changing details in the product characteristics, introducing new manufacturing facilities, introducing a new API (Active Pharmaceutical Ingredient) manufacturer, extending the shelf life and so forth.
• FarmaliRA Consulting assists you in preparing the submission of variations on your Marketing Authorisation (MA) and achieving approval quickly and efficiently.
Many pharmaceutical companies are changing the location of their manufacturing sites, mostly to India and China. There is a considerable increase in the EU Qualified Person’s task to release the imported finish products to the EU countries.
• FarmaliRA Consulting assists you by acting as the EU QP of your company.