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Post Approval Lifecycle Maintenance for Pharma & Medical Devices
Product lifecycle management: Post approval maintenance, support during merger and acquisition, Artixio supports pharma and devices companies with managing compliance for marketed products globally.
Services We Offer
Artixio, Your Partner for Global Product Lifecycle Compliance
With a solid team of experienced Regulatory and Pharmavcovigilance professionals in global markets, pharmaceutical and device companies trust Artixio with compliance and growth of their products portfolio. Right from Regulatory and Product Lifecycle strategy, continuous intelligence and monitoring to managing health authority relations and negotiations, Artixio has proven experience in delivery excellence leveraging its global project management and best practices.
← End to End Global Product/Market Ownership for Post Approval Lifecycle Maintenance →
Regulatory Strategy
- Regulatory Framework
- Regulatory Intelligence
- National & International for All Application Types
Dossier Preparation & Submission
- M1, GMP, QP Documentation
- eCTD / ACTD Submissions
Advertising and Labeling
- Product Claims
- Labeling
- Ad-Promo Review
- Cross-Functional Regulatory Guidance
Cross Functional Communication
- Primary RA Responsibility
- Scientific Communication
- RA Guidance on Tender, Market Access, Commercial
Post Approval Maintenance & Reporting
- HA Payments Review & Approvals
- RIMs update and management
PV
- DSUR/PSUR Submissions
- RMP Updates
- HA Queries Response
Critical Issues Management
- Risk based Decision Support (Special Access, Compassionate Use)
- Import Permits, Clearances
RA Representation during Audits
- Audit Preparation
- Audit Support
- Response to Queries
- SDEA renewal
- SDEA archival
Health Authority Representation & Negotiation
- Represent client for all HA communication
- Negotiate Timelines, Extensions, Critical Scientific Situations
Enabling Access to Innovation Globally
Driven by key regional regulatory and market insights, Artixio aims to enable seamless access to lifesciences innovations for patients and end users globally by simplifying regulatory processes.
Commitment to Excellence
With proven experience from successful approvals and key learnings from different markets across product and therapeutic categories, Artixio is committed to excellence by implementing best management and regulatory practices geared towards efficient, reliable solutions for our customers’ regulatory needs.
Ensuring Compliance
Our centralized view of global regulations and strategies to approach diverse, complex markets enable us to ensure compliance of multiple products across multiple markets on ongoing basis.
Your Global Partner for Post Approval Lifecycle Maintenance
- Global Team of Regulatory Professionals with 5-35+ years of Experience
- Proven Experience in Managing Health Authority Expectations and Negotiations
- Bilingual Proficiency – English and Regional Language
- Diverse Experience – Pharmaceutical, Biologics, NCEs, Medical Devices and OTC
- Secure IT Environment for Global Operations – Enabled Through Remote Access
- Flexibility to Adapt to Your Changing Business Needs
- End to End Product Lifecycle Management Experience
- Established Processes to Manage Complex Regulatory Functions
- Long Term Relationship with both Clients and Employees
- MA Holder / Legal Representation in Several Countries
On-Demand Post Approval Lifecycle Support Solutions
Regional Cost Advantage, Reduced Overheads, Risk Adjusted Pricing Model
Long Term Contracts, Cross-Functional Trained Teams, Back-Up Resources
FAQs
1. What exactly happens after a product gets approved?
Getting regulatory approval is a big step, but it’s not the finish line. After approval, there’s an ongoing need to manage product updates — whether it’s a change in packaging, adding a new manufacturing site, or addressing updated safety info. All of this needs to be reported to health authorities, often in a structured format and under tight timelines.
2. Why is post-approval maintenance needed in the first place?
Because things change — suppliers, processes, regulations. Authorities want to stay informed about any shift that could impact the product’s safety, quality, or performance. If updates aren’t handled correctly, companies can face delays, fines, or worse — a suspension of marketing rights.
3. Are pharma and medical devices handled the same way?
Not quite. Pharmaceuticals usually involve variation types (like IA, IB, or II) with specific timelines and documentation. Devices, on the other hand, follow post-market surveillance rules under MDR or local regulations, which require regular technical documentation updates and vigilance reporting. The goals are similar, but the paths are different.
4. What does post approval lifecycle maintenance include?
Once a product is approved, the work doesn’t stop there. You’ll still need to manage changes like manufacturing updates, label modifications, safety-related adjustments, or shifts in regulatory requirements. Post approval maintenance ensures all those changes are documented, approved, and compliant in every market where the product is sold.
Still Have Questions ?
Specialized Regulatory Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Regulatory Services Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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