105 Ashford Dr
Plainsboro, NJ 08536
ph: 609-903-5305
newton@dnpsllc.com
Copyright 2013 Dr Newtons Pharma Solutions
LLC. All rights reserved.
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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
"Transforming Ideas into Technology "