Central and local outsourcing of global regulatory affairs and operations services
PLG offers a comprehensive bundle of regulatory services to biopharmaceutical companies to roll-out and maintain their portfolio of products, ensuring continuity of supply and patient access to high-quality, safe, and efficacious products.
Our regulatory added-value for product lifecycle maintenance: ensuring compliance and efficiency
Our global team of regulatory professionals and project management experts have significant expertise combined with decades of experience. This experience and insight have enabled us to create innovative and industry-leading methodologies to support product lifecycle maintenance for our customers.
Our solution combines global project management, central staffing, and local experts for the complete outsourcing of post-approval regulatory activities.
Robust, proven transition and project start-up activities ensure seamless transfer of product responsibilities from the client to our team.
Right first-time delivery and complete and transparent reporting of metrics, including submission, approval, and implementation status, give our customers the assurance they require that their products remain fully compliant and marketable.
Project scope and definition of services
An articulated description of the full range of services to be provided by our team establishes the framework required for successful delivery.
Project implementation and transition of services
Proven methodologies to rapidly define processes, roles, and responsibilities, systems access, training and onboarding, and product knowledge transfer ensure a seamless transition of services.
The right-shored team supported by robust governance
Our solution balances local in-country expertise with right–shored operational staff to maximize quality and cost-effectiveness, supported by strong governance and oversight from seasoned leaders.
Project delivery and expertise
Our team will meet all your regulatory affairs, operations, and CMC staffing needs. This support is combined with project management to ensure you have the right level of governance.
Flexible solution designed to evolve with your needs
Our services evolve to support process optimization, effectively use new technologies and software solutions, and ensure compliance within an ever-changing regulatory environment.
PLG added-value: tailored regulatory support to maximize ROI in regulatory product maintenance
Our tailored and flexible solution helps our customers achieve their business objectives by maximizing the “Return On Investment” (ROI) for outsourced product maintenance activities that ensure product compliance.
PLG can provide ‘follow the sun’ solutions by fully engaging our global delivery platform, enabling E2E outsourcing and RA support services covering Global business hours. PLG will work to harmonize and optimize partnership processes while our experts help navigate the increasing complexity of regulatory affairs and operations, liberating valuable internal resource capacity.
We are an entrepreneurial company at heart. This ethos allows us to be agile and responsive and to provide quick responses and turnaround times.
PLG experience: offering tailored E2E product lifecycle support for more than 30 years
We have many years of experience partnering with multiple customers for their product Lifecycle maintenance requirements. We provide comprehensive end-to-end regulatory support, including strategy, document authoring review, submission compilation, Dispatch, and systems updates. Our solutions are tailored to meet the specific needs of the customer. We have deep experience with local regulatory in-market support covering over 150+ markets, providing direct contact with agencies if required. We support market expansions and maintenance submissions and offer complete regulatory operations expertise in publishing, RIM, labeling, and translation support.
Case Study: Maintenance activities through its regulatory affiliate model across global markets.
The Central-Local Outsourcing Operating Model (Cl-O₂ model) was utilized, placing PLG in a robust collaboration with the client, facilitating PLG to execute local regulatory affairs activities within the parameters of the project scope.
Our team was able to provide complete oversight and successful execution of all planned activities and to react quickly to the client’s ad hoc requests.
Key deliverables:
- EU lifecycle management
- Provision of local Regulatory Intelligence Inc. clinical trial requirements
- Updates on support of the safe and effective use of medicines
- Management of CPPs
- Artwork reviews and linguistic reviews
Key Figures:
- 35 European countries, including Switzerland, the UK and Ukraine
- 55 HC spread between our Local and Central RA groups
Case Study: Global Lifecycle management, including standardized submission processes and local regulatory intelligence.
Support the strategic roll–out plan and speed up the Go-To-Market in 90 countries. Regulatory Operations: ensure US/EU/Asian operations and expertise to support business continuity and absorb high volume for strategic projects.
Key deliverables:
- Project Management
- Budget control
- Strategic Planning
- Global Reg Intelligence
- Lifecycle management
Key Figures:
- Worldwide coverage: North America, LATAM, Europe, MEA and APAC
- 85 HC spread between our Local and Central RA groups