Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.
Contact our specialists to tailor a service plan
After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use. However, maintenance obligations must continue to be met in all regulated areas.
To retain Marketing Authorization, the MA holder must continually:
- Update work to ensure the approved dossier is valid
- Address safety surveillance issues by having pharmacovigilance systems in place
- Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
- Respond to renewal requirements, as necessary
Challenges that accompany large product portfolios, differing global markets, evolving regulatory landscapes, and stakeholder expectations can further increase the complexity, unpredictability and intensity of the Post-approval Phase.
Changes in development and regulations require continuous updates to systems, documents and agreements. Consequently, time and resources may be strained, causing new product development to suffer.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Smart Technology + Savvy Humans = Brilliant Solutions
With over 33 offices around the globe, our highly specialized network customizes optimal, region-specific solutions for the Post-approval Phase.
Emerging Smart technologies employ computerized and automated service lines, including our PharmaLex Partnerships database, to free up time and resources—so you can focus on what is important.
Discover technology that helps you:
- Orchestrate all global activities for GxP management within a single cloud solution
- Automate case processing and safety literature
- Audit incoming case safety reports
- Manage pharmacovigilant agreements
- Transition to a fast, holistic solution for paperless compliance
- Evaluate possibilities with the Risk Assessment Tool for Excipients (RATE)
- Analyze GxP vendor metrics
PharmaLex has long-standing and extensive experience of interacting with the scientific committees and working parties of the EMA (e.g. CHMP, PRAC, COMP, PDCO, CAT) and with national Health Authorities. We frequently support our clients in Scientific Advice procedures at a national or central level, and in numerous health authority interactions throughout a product’s lifecycle (e.g. requests for PRIME eligibility, Orphan Medicinal Product designations, Pediatric Investigational Plans, Marketing Authorization Applications).More Info
With over 75 CMC consultants across the globe, PharmaLex has substantial CMC expertise across all areas. We are able to offer an integrated solution combining the scientific, technological, non-clinical, clinical and regulatory expertise with our broad global project experience to meet your specific needs, from discovery to licensing and post-approval.More Info
CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.More Info
eCTD, System Operations and Data Management
Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation.More Info
Regulatory Writing / Scientific and Technical Writing
PharmaLex offers scientific, regulatory and technical writing, supporting clients in the development of medicinal products.More Info
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