Medical Product Life-Cycle Management for Pharmaceuticals and Device Products
Post-approval maintenance, support during mergers and acquisitions ā Pharma Wizard supports pharma and device companies in managing compliance for marketed products globally through comprehensive Medical Product Life-Cycle Management.
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Pharma Wizard for Your Product Lifecycle Maintenance Solutions
End to End Global Product/Market Ownership for Post Approval Lifecycle Maintenance ā
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
Commitment to Excellence
Ensuring Compliance
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 ā English and Regional Language
- Diverse Experience ā Pharmaceutical, Biologics, NCEs, Medical Devices and OTC
- Secure IT Environment for Global Operations ā 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 Services
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Significant Cost Savings:
Regional Cost Advantage, Reduced Overheads, Risk Adjusted Pricing Model - Centralized Knowledge Repository, Records and Training
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Business Continuity:
Long Term Contracts, Cross-Functional Trained Teams, Back-Up Resources - Since Project Management PoC for seamless oversight
FAQS
What are different type of documents authored through medical and Technical writing?
Medical Writing requires professionals and clinical and regulatory background who author high quality clinical and regulatory documents for multiple purposes based on clinical data available through studies or literature review and regulatory guidelines. Medical writing helps prepare documents for clinical development such as clinical study reports, investigator brochures, protocols, clinical summaries. For safety purposes, documents such as periodic safety update reports, development safety update reports etc. For patient communication and safety purpose, core labelling documents and educational and promotional materials are prepared using medical writing.
Technical writing requires Chemistry Manufacturing and Controls professionals who can develop reports and documents for SOPs, development and validation reports, regulatory filings and other requirements.
Pharma Wizard provides medical and technical writing services to meet the regulatory requirements from global health authorities.
How do you support Medical Writing for multiple countries?
Pharma Wizardās team includes medical writing professionals based in multiple regions including the USA, Europe and Asia. Our team members have experience (10ā20+ years) authoring critical documents supporting complex therapies through development, launch and post market support.
What challenges do companies face in medical and technical writing and how do you address them?
Both medical and technical writing require a solid command on the subject and proven experience across therapeutic area, clinical development, comprehensive literature search and review strategy, CMC experience, preparation of analytical reports and others. It also requires ability to analyse the data and present in structured format acceptable by international standards. Proficiency in language and ability to communicate effectively suitable to the audience and the purpose of the document is key. Organizations worldwide often lack one or more of these capabilities. Besides, the requirement for medical and technical writing could be short to mid term where companies may need the professionals for few months and therefore, they need external support to augment resources to meet immediate requirements.
Pharma Wizard addresses these challenges by providing flexible, budget friendly and timely pharmacovigilance services including LQPPV using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.
How do you work with global pharma and devices companies for medical writing?
Pharma Wizard offers flexible business models suitable to diverse company sizes, project and resources requirements, regions and therapy areas. Our business models include project based, long term managed services, staffing model (both onsite and offsite) in a economic pricing model.
