PLG North America
PLG North America (PLG NA) is the North American affiliate of Product Life Group (PLG) LLC. PLG is a global leader in supplying targeted SME contract employees to emerging pharma and biopharma and has been operating in the US for many years from its European base. With the acquisition of DSI, PLG made the decision to increase their visibility to US-based clients by branding PLG North America as their US-based resource. The primary focus of PLG NA is to assist domestic or international clients in managing their workload in a cost-effective manner in support of clients ongoing submissions to the FDA.
PLG North America supplies technical SMEs in North America domestically in Quality and Regulatory roles to meet the clients’ needs for short-term project assistance that don’t require the time, commitment and cost of hiring full-time employees by the client. Technical specialists under the guidance of an experienced project manager are able to quickly undertake tasks for clients with either a remote or onsite presence and provide the extra resources needed to meet a tight timeline or manage a bolus of work during submissions or FDA interactions.
PLG NA SMEs can handle a wide variety of tasks for clients including publishing, proofreading, advertising promotion, archiving, labelling, translation, authoring of technical documents in support of FDA submissions. SMEs can be within the same time zone or only a time zone distant facilitating communication with your new team member.
900+
Subject Matter Experts
650+
Projects per Year
Services
1. Due Diligence of CMC and Quality Modules
2. Pharmaceutical Development Management
3. Preparation of Scientific Reports
4. Full CMC Writing
5. GxP Audits & Compliance
6. Quality Assurance Management
7. Local Qualified Person
8. Quality Management System Writing
1. Development of Non-Clinical & Clinical Strategy
2. Due Diligence of Non-Clinical & Clinical Studies
3. Drafting or Update of Non-Clinical & Clinical Modules
4. Support for Scientific Advice Meetings
5. Full Non-Clinical & Clinical Study Management
6. Medical Writing: Environmental & Pediatric Studies
7. Bioequivalence & Bioavailability Studies
1. Global Regulatory Intelligence & Strategy
2. Pre-Submission Meeting with Health Authority
3. Module 1 & Dossier Preparation
4. Market Authorization
5. Submission & Deficiency Management
6. Labeling Linguistic/Artwork Review
7. Life Cycle Maintenance
8. Suite of Readability Testing Services
1. Data & Document Management
2. Regulatory Information Management System (RIMS)
3. eCTD Formatting, Publishing, and Submissions
4. Labeling: Package inserts (PI), Structured Product Labeling (SPL), container, and carton labeling
5. Dossier Translations
6. Facility Registrations
1. Medical Information
2. Case Management
3. Literature Monitoring
4. Medical Writing: PSUR, PSMF
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