Assure the quality and compliance of your pharmaceutical products with help from our experts
To complement your product development and manufacturing, our team of experts possesses in-depth knowledge and extensive experience in a comprehensive range of professional services: regulatory affairs, pharmacovigilance services, and quality assurance activities, including import and release services.
- Regulatory Affairs
- Phamacovigilance services
- Drug-device combinations
- Qualified Person & Responsible Person
For a full description of our quality and regulatory services, including import and release:
Regulatory Affairs
Regulatory affairs hold no mystery for us. We can help you navigate the sea of acronyms and regulations to ensure you comply with the necessary regulations for your product.
We advise on regulatory strategy and EU legislation, as well as carrying out regulatory due diligence and assessing registration dossiers on your behalf.
Pharmacovigilance services
Basic Pharma’s support does not end when your drug hits the market. We can help you set up your pharmacovigilance system and assist with the creation of the necessary documents.
We are available 24/7 to help you to monitor the effect of your drugs during clinical studies and after they have been licensed for use.
Drug-device combinations
Basic Pharma offers regulatory and quality systems consulting services for any delivery systems related to your drug product, including:
- Delivering a person responsible for regulatory compliance (PRRC) to your company
- Regulatory consulting
- Quality systems consulting
- ISO 13485 gap-analysis
- ISO 13485 audits
- Compilation of CE product dossiers
Qualified Person & Responsible Person
Basic Pharma’s dedicated professionals have been responsible for our successful maintenance of Good Manufacturing Practices (GMPs) for many years. We have gained substantial expertise in the field of Quality Assurance and Quality Control and built a comprehensive, GMP-compliant, Quality Management System (QMS).
This means we can now share our knowledge with other organizations in need of professional support or advice in this area.
We offer services and consultancy support on a range of Quality and Qualified Person Services, including:
- Quality Management Systems (QMS)
- GMP implementation and maintenance
- Auditing, monitoring and training
QP release of the Drug Product
One of the most critical aspects of the GMP-based quality system is the final batch release of a product. To ensure the product has the required quality, the product and the documentation listed in the product specification file (PSF) must be reviewed by an independent Qualified Person (QP).
Basic Pharma’s QPs are experienced in both commercial and non-commercial batch release.
