Continuous evolution in science and changes in the regulatory environment and health sector, creates the need for professional regulatory guidance throughout the lifecycle of a healthcare product.
Our 20 years’ experience in multidisciplinary projects, along with our team’s continually grown knowledge and expertise on regulatory policies and procedures enables Lamda to offer clear strategic guidance in order to ensure a short and cost-effective path to the market, of a high quality product that will maintain its quality properties throughout its lifecycle.
Lamda’s regulatory team comprises of experts experienced in several regulatory fields. Our main target is to meet our clients' expectations while ensuring the compliance with all regulatory requirements to expedite the development and delivery of safe and effective healthcare products to individuals around the world.
The regulatory affairs department of Lamda offers a wide range of services including:
- Continuous monitoring throughout the development of the pharmaceutical product
- Evaluation of regulatory information and documentation for the compilation of a registration dossier according to the highest standards.
- Designation of regulatory strategy
- Review and evaluation of administrative data
- Compilation and organisation 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) e-CTD
- Registration of pharmaceutical products through national, mutual recognition and decentralised procedures
- Risk assessment reports (e.g. ERA, Elemental Impurities (Q3D))
- User Testing
We devise and implement product specific development strategies capable of delivering high-quality formulations and robust manufacturing processes.
Our state-of-the-art laboratories offer a wide range of analytical services to support your exact needs under strict quality procedures which meet GMP requirements and following ICH guidelines.
In applications for Generic and Generic Plus medicinal products, the concept of bioequivalence is fundamental.