Life Cycle Management
From the initial application to any post-approval modifications, we have a thorough understanding of regulatory life cycle management and offer a wide range of services to ensure continuous regulatory compliance.
Regulatory Strategy Development:
- Custom strategies for submission and approval
- Support for pharma and biotech products
Regulatory Intelligence and Compliance:
- Monitoring global regulatory changes
- Ensuring ongoing compliance
Product Variations Management:
- Major Variations: Product changes, processes, indications
- Minor Variations: Labelling, administrative, packaging updates
- Separate and Grouping Variations: Process optimisation
Product Renewal:
- Strategic planning and preparation for renewals
- Timely submissions to ensure uninterrupted marketing authorisation
Market Authorisation Transfer:
- Inter-regional and intra-regional MA transfers
- Compliance with all relevant authorities
Labelling and Product Information Management:
- Global labelling compliance
- Strategic product information updates
Trusted by top-tier teams worldwide
FAQs
We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Our team has extensive experience in Advanced Therapy Medicinal Product (ATMP) clinical development and is well-versed in how to deliver compliance throughout the development process. Get in touch with us for further information.
Featured case studies
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…