105 Ashford Dr
Plainsboro, NJ 08536
ph: 609-903-5305
newton@dnpsllc.com
Plainsboro, NJ 08536
ph: 609-903-5305
newton@dnpsllc.com
Copyright 2013 Dr Newtons Pharma Solutions
LLC. All rights reserved.
LLC. All rights reserved.
Services
Dr. Newtons Pharma Solutions LLC offers contract development and consultant services on a
wide range of research and manufacturing activities
Generic / New Drug Product Development and Contract Manufacturing
• Oral Dosage forms - Solid, liquid, suspension, modified release
• Parenteral Dosage forms - Aseptic fill finish / Lyophilized Vials and Prefilled syringes
• Topical lotions and creams; Ophthalmic and Otic solutions / suspensions
• High Potent drug products, Cytotoxic Products, DEA controlled substances
• Screening CMOs, technology transfer
• Manufacturing Process Validation
• Active Pharmaceutical Ingredient (API) Synthesis
CMC Development and Management
• Product Development for NDA, ANDA and 505(b)2 NDA
• Patent analysis, review and offer strategies to PIV or 505(b)2 opportunities
• Managing manufacturing operations with CMOs
• CMC Due diligence
Regulatory and Quality Management
• Regulatory Support for Pre-IND, IND, NDA, ANDA, 505(b)2 NDA, and DMF
• US FDA Regulatory Agent Services for New and Generic Products
• cGMP and quality compliance support, review manufacturing site for regulatory PAI
Analytical Research and Development
• Analytical Methods development and validation
• Cleaning Methods development and Validation
• Product Characterization, reverse engineering, Physico-chemical testing
• In-Vitro bio-equivalence testing methods development and validation
Business development
• ANDA / DMF Product partnership proposal
• Business partnership development for ANDA products
Dr. Newtons Pharma Solutions LLC offers contract development and consultant services on a
wide range of research and manufacturing activities
Generic / New Drug Product Development and Contract Manufacturing
• Oral Dosage forms - Solid, liquid, suspension, modified release
• Parenteral Dosage forms - Aseptic fill finish / Lyophilized Vials and Prefilled syringes
• Topical lotions and creams; Ophthalmic and Otic solutions / suspensions
• High Potent drug products, Cytotoxic Products, DEA controlled substances
• Screening CMOs, technology transfer
• Manufacturing Process Validation
• Active Pharmaceutical Ingredient (API) Synthesis
CMC Development and Management
• Product Development for NDA, ANDA and 505(b)2 NDA
• Patent analysis, review and offer strategies to PIV or 505(b)2 opportunities
• Managing manufacturing operations with CMOs
• CMC Due diligence
Regulatory and Quality Management
• Regulatory Support for Pre-IND, IND, NDA, ANDA, 505(b)2 NDA, and DMF
• US FDA Regulatory Agent Services for New and Generic Products
• cGMP and quality compliance support, review manufacturing site for regulatory PAI
Analytical Research and Development
• Analytical Methods development and validation
• Cleaning Methods development and Validation
• Product Characterization, reverse engineering, Physico-chemical testing
• In-Vitro bio-equivalence testing methods development and validation
Business development
• ANDA / DMF Product partnership proposal
• Business partnership development for ANDA products
| Dr Newtons Pharma Solutions LLC |
"Transforming Ideas into Technology "
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