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-IVDR Technical File Remediation
EU-IVDR Technical File Remediation Introduction In Vitro Diagnostic Manufacturer Our client is a leader in high-quality, innovative diagnostic products for the determination of blood groups (anti-Duffy and anti-Kidd). They are located in the US with operations globally. Standards & Tools EU-IVDR 2017-746 ISO 13485 ISO 14971 GDPR Word Excel Powerpoint Scope of work Key numbers…
Regulatory Strategy IVDR / FDA
Regulatory Strategy IVDR / FDA Introduction Deciphex Deciphex is a digital pathology workflow and integrated AI platform for research pathology, CROs and pharmaceutical companies for handling high volume drug safety pathology studies. They provide a complete GLP-compliant workflow with integrated AI screening capabilities. Standards & Tools Scope of work Brian – Director QA RA As…
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…
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