Sun Source Pharmaceuticals’ in-house legal department offers diverse expertise covering the entire spectrum of regulatory, commercial, intellectual property, and litigation functions necessary for ANDA development, submission, prosecution, and approval.
- Patent analysis from initial review to full FTO opinion
- Legal and Regulatory due diligence for new opportunities
- Support for ANDA submission/prosecution
- Paragraph IV-litigation defense and management
Our dedicated in-house litigation team has diverse experience in Federal and State courts across the United States, including Waxman-Hatch Paragraph IV litigation.
Sun Source Pharmaceuticals provides warehouse, storage, inventory management and fulfillment services for its charter customer RABSKVI HEALTH, Inc. We are located in LANCASTER PA, and the facility is licensed by the State of PA, Department of Business and Professional Regulation, as a Third Party Logistics Provider (3PL) & Reverse Distributor.
We are a full service 3PL that provides innovative logistics support where additional knowledge, specialization and outsourcing are required. The company’s business operations are tailored to service RABSKVI HEALTH’s wholesale distributors and retail pharmacy customers or prescription pharmaceutical drug products.
Sun Source Pharmaceuticals’ facility is a secure climate controlled environment that is properly licensed to meet FDA, cGMP, PDMA, DEA, VAWD and other regulatory requirements. SUN SOURCE’s services to RABSKVI HEALTH, INC provide a hands-on, efficient processing of supply chain functions for its customers.
Regulatory / Technical Operations
Sun Source Pharmaceuticals’ Technical Operations department offers a wide variety of expertise encompassing Regulatory Affairs, Quality Assurance, Technical Services and Clinical Affairs, supporting Product Development through ANDA submission, approval and product launch.
Our Product Development team provides support services from inception to launch:
- Qualification of API suppliers
- Development support
- Collaboration with finished-dose manufacturers on a global basis
- Quality by Design
- Compliance assurance with FDA standards
- Launch support
Our Regulatory Affairs team has extensive experience with compilation & submissions of ANDAs to FDA, providing:
- Advice to domestic and foreign partners on US regulatory requirements
- Liaison with FDA at all stages of ANDA prosecution, including Deficiency Responses
- Analysis and implementation of new and changing FDA Regulatory Guidance, Regulations & Compliance
- Fully-validated eCTD submission services
- ANDA support through Post Approval (Drug Listing, Labeling Changes, Annual & Periodic Reports, Supplements)
Our Quality Assurance/Technical Services team handles all of the following:
- Pharmacovigilance – in collaboration with Regulatory Affairs
- SOPs – comprehensive coverage of Quality System elements
- cGMP Compliance Audits of contract labs, CROs, and Manufacturers
- Labeling: Oversight of all FDA requirements for content and format
Our Clinical Affairs team provides expertise in:
- Selection, Qualification and Monitoring of CROs for cGCP compliance
- Development of bio-equivalence strategies
- Sponsorship /management of bio-equivalence studies
Sun Source Pharmaceuticals also has extensive experience concerning the regulatory requirements for Dietary Supplements and Medical Foods.