FarmaliRA Consulting offers Regulatory Affairs, Quality Assurance and Pharmacovigilance services for pharmaceutical companies (human, veterinary and herbal) .
Available services include:
- Interim management RA department
- Interpretation of regulatory guidelines
- Compilation of dossier texts
- Creation of dossiers in Common Technical Document (CTD) format (modules 2 and 3)
- Preparation and submission of Marketing Authorisation Applications according to National/Mutual Recognised Procedure /Decentralised Procedure
- Responding to Regulatory Authority requests.
- Life Cycle Management (preparation and submission of variations, line extensions, renewals). The post-approval variations to the marketing authorisation, such as:
- changes to manufacturing facilities or the process
- changes to product characteristics or presentation of the product
- extension of shelf-life
- changes to the product information (SPC/PIL/ Labelling)
- GMP/ QA system support
- Batch release of Active Pharmaceuticals Ingredients (API)
- Qualified Person (QP) for batch release of Finished Products
- Preparation and submission of Manufacturer/Importer Authorisation
- Pharmacovigilance system support
- Preparation and submission of Risk Management Plan (RMP)
Available services include:
- Interim management RA department
- Interpretation of regulatory guidelines
- Compilation of dossier texts
- Creation of dossiers in Common Technical Document (CTD) format (modules 2 and 3)
- Preparation and submission of Marketing Authorisation Applications according to National/Mutual Recognised Procedure /Decentralised Procedure
- Responding to Regulatory Authority requests.
- Life Cycle Management (preparation and submission of variations, line extensions, renewals). The post-approval variations to the marketing authorisation, such as:
- changes to manufacturing facilities or the process
- changes to product characteristics or presentation of the product
- extension of shelf-life
- changes to the product information (SPC/PIL/ Labelling)
- GMP/ QA system support
- Batch release of Active Pharmaceuticals Ingredients (API)
- Qualified Person (QP) for batch release of Finished Products
- Preparation and submission of Manufacturer/Importer Authorisation
- Pharmacovigilance system support
- Preparation and submission of Risk Management Plan (RMP)