Continuous evolution in science and changes in the regulatory environment and health sector, create the need for professional regulatory guidance throughout the lifecycle of a healthcare product.
Our accumulated experience in multidisciplinary projects, along with our team’s continually growing knowledge and expertise on regulatory policies and procedures enables Lamda Laboratories to offer clear strategic guidance in order to ensure a short and cost-effective path of a high quality product to the market that will maintain its quality properties throughout its lifecycle.
We offer a wide range of services including:
- Research and development, risk assessment and management
- Continuous monitoring throughout the development of the pharmaceutical product
- Organization and monitoring clinical trials and BE studies under GCP compliance
- Evaluation of regulatory information and documentation for the compilation of a registration dossier according to the highest standards.
- Designation of a regulatory strategy
- Review and evaluation of administrative data
- Clinical and non-clinical medical writing from our highly qualified experts’ team.
- Compilation and organization of data for pre-submission reports/scientific advice
- Liaising with regulatory authorities across Europe for submissions, RFIs, variations, renewals
- Electronic submissions (applications, variations, renewals, deficiency letters from clients/authorities)
- Registration of pharmaceutical products through National, Mutual Recognition and Decentralized procedures
- Post-market surveillance and vigilance, distribution, inspections and sales