OUR SERVICES

WE HELP DEVELOP AND

BRING NEW PRODUCTS TO MARKET

We specialize in commercializing new products and services in the animal and human health industries.  We can turn insights into tangible opportunities and foster the development of those opportunities into commercialized realities.  

 

​Our team is composed of professionals in diverse and complementary areas of expertise.  With an average of 20+ years of experience in the industry, we have developed and/or launched over 15 blockbuster and top tier products in the prescription and OTC channels over our careers. We have experience in most indication area including antimicrobials, cardiology, dermatology, endocrinology, gastrointestinal, oncology, pain management, parasitology, food animal indications and equine.

We are champions of innovative solutions and understand what it means to be a part of an integrated and collaborative team. We have strong relationships with each other, with our clients and throughout industry.

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INNOVATION STRATEGY

  • Financial Valuations of New Opportunities

  • Key Opinion Leader (KOL) Strategy and Advisory Board Development

  • Product Acquisition or In-License Strategies and Negotiations

  • Product Ideation

  • Product Re-positioning and Label Extension Strategy

  • Product Profile Development

  • R&D Pipeline Assessments

  • R&D Strategy

CLINICAL DEVELOPMENT

MARKETING & SALES STRATEGY

  • Brand/Category Strategy

  • Brand Planning and Execution

  • Communication Strategy

  • Marketing Collateral Development

  • Post-approval Marketing Strategy and Protocol Development

  • Product Forecasting

  • Product Launch and Re-Launch Strategy

  • Product Training

  • Publication Strategy

  • Sales and Distribution Strategy

QUALITY ASSURANCE & COMPLIANCE

  • Audits of Systems, Standard Operating Procedures,  Processes and Training Programs 

  • Baseline QA Assessments

  • Clinical Investigator Site Audits, Database Audits and Study Report Reviews

  • Development of Clinical Quality Assurance (CQA) Programs

  • Host Regulatory Inspections for Sites with No Onsite Quality Present

  • Inspection Readiness Preparedness and Training 

  • Mock Inspections

  • Pre-Approval, Vendor and Supplier Audits

  • Biostatistics and Analysis from Planning to Submission

  • Clinical Trial Management

  • Clinical Research Organization (CRO) Negotiations and Management

  • Data Management, Data Summary and QC

  • Final Study Report Writing

  • Laboratory Support

  • Protocol Strategy & Development

  • R&D Project Management

  • Study Design

  • Study Monitoring

  • Statistical Analyses

  • Study and Technical Training

  • USDA Regulatory Clinical Trial Management (Non-GxP and GCP)

THIRD PARTY MANUFACTURING

  • API and Drug Product Validation

  • CMC Preparation

  • Contract Manufacturer Organization (CMO) Negotiations and Management

  • FDA and EPA Third Party Pharmaceutical Technical Development

  • Process Technology Transfers

  • Protocol Development and Execution

  • Technical Analytics and Formulation Chemistry

  • Third Party Packaging Development

SUPPLY CHAIN & COMMERCIAL OPERATIONS

  •  Commercial Operations, Customer Service and Order Fulfillment Management

  • Distribution Strategy, Negotiations and Distribution Network Optimization

  • Industrial Chemical, Pharmaceutical and Medical Device Supply Chain Management

  • Master Resource Planning (MRP), Production Planning and Forecasting [SAP]

  • Sales and Operations (S&OP), Sales, Inventory and Operations Planning (SIOP), Sourcing and Implementation  

 

5820 N. Church Street, Suite D#213, Greensboro, NC 27455 | 336.209.4941
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