Pama Reis Consulting offers a wide range of services, be it a one-off or a long-term project with hourly or monthly fees.
Browse below some of the services we currently provide.
New MA applications and MA maintenance
- New MA applications – Preparation, submission and maintenance (national, mutual recognition, decentralized and centralized procedures, in NeeS and eCTD)
- Compliance
- Preparation/Review of MA dossier documentation
- Regular contact with Competent Authorities
- SmPC, PIL and Labelling review
- MA variations Type I (IAin, IA, IB) and Type II
- MA renewal
- MAH transference
Economic Assessment
- Prices – new application and annual review
- Previous assessment of medicinal products
- Reimbursement application
- Early Access Program
Marketing
- Review of promotional materials
- Notification of promotional materials to the Competent Authorities
- Publicity and Transparence Management (ToV, events)
Pharmacovigilance
- Periodic Safety Update Reports
- Pharmacovilance SOPs
- Notification in Eudravigilance
- Bibliographic research in national and international literature
Licensing
- Application to obtain distribution authorization for Medicinal Products
- Application to obtain distribution authorization for Medical Devices
- Preparation and implementation of Quality System
Medical Devices
- Preparation and review of labelling and instructions for use
- Notification to the Competent Authorities
- Medical Devices Vigilance
- CNP management (product national code)
Cosmetics
- Product Information File (PIF)
- Safety Assessment Report
- Preparation and review of labelling and instructions for use
- Notification in CPNP
- Cosmetovigilance
- CNP management (product national code)
Food Supplements
- Preparation and review of labelling and instructions for use
- Notification to the Competent Authorities
- CNP management (product national code)
Other products
- Regulatory management of other health products (biocides, medicinal gases, herbal products, veterinary products)
Others
- Support in company meetings (in-house or other)
- Medical Sales Representatives credentials
- Training
- Translation of scientific documents
- Support in Quality Assurance Management
- Support and presence in internal/external audits and inspections
Quality Commitment
Each client will have
Personal, independent and confidential support at all phases of the project
Scrupulous fulfilment of all agreed deadlines and budgets
Adaptation to personal requirements and organization, regarding meetings and in-house/external work
Full dedication to ongoing projects