Regulatory Affairs
- Advice on the regulatory strategy of the product.
- Assistance to request Scientific Advice from Health Authorities
- Evaluation and preparation of dossiers.
- Assessment of variations to the dossier.
- Support on defficiency letters.
- Preparation of pre-clinical and clinical sections
- Preparation of Investigational Medicinal Product Dossiers (IMPDs)
- Readability tests.
- Preparation of documentation for the application for registration of the company as Marketing Authorization Holder:
- Development and design of the Quality Manual
- Preparation of the MAH Technical Report
- Preparation of Quality System SOPs and associated record sheets
- Advice and technical support to adapt your company to good distribution practices (GPD): Support, advice and preparation of all marketing authorisation holder (MAH) documentation until obtaining the Authorization and GDP Certificate