Advanced Medical Technology Company Investment Opportunity in South Plainfield, United States

- Our business, founded in South Plainfield in 2015, offers a full range of technologically advanced services.

- We provide contract testing and product development services to pharmaceutical and nutraceutical industries.

- Have more than 30 clients.

- Represent our clients at FDA, EPA, DEA in US regulatory proceedings.

- We also provide on-site CGMP audit by qualified auditors, analytical and microbiological support, cleaning validation studies, stability studies.

- Our staff has an extensive experience interacting with FDA at both district and headquarters level.

- Our experts have a strong record of successful filings, more than 50 approved ANDAs.

- Our team of scientists have extensive experience with FDA and ICH guidelines.

- Our regulatory experience helps our customers develop practical and sound regulatory strategies.

- Promoter has more than 5 years of experience in this business.

Process design, development and optimization, CGMP audit support for manufacturing facilities and contract testing laboratories, process validation documentation support and sample testing, development of analytical methods, qualification and validation, preparation of papers and submission of ANDAs, preparation and submission of supplements and modifications, preparation and submission of site modifications and tech tracks, Qualification and validation, USP / NF methods Verification, release testing of active pharmaceutical ingredients (APIs), excipients and finished products, stability development indicating techniques, stability programs and stability surveys, Dissolution testing of instant and extended release products, determination of test profiles, development of methods and validation of cleaning research, finished product testing for potency and impurities level and validation services, documentation support.

Owned 6,000 Sq Ft state of the art modern facility located in the Industrial Park, single store building.

Analytical capabilities: Gas Chromatography (GC), Head Space Gas Chromatography, UV Liquid Chromatography (HPLC), DAD, RI detectors, FT-IR, UV-VIS, Atomic Absorption, Dissolution Apparatus, Auto titration including KF Water determination.

Product development capabilities: High Shear Mixture / Disperser / Emulsifier Ross Mixture, IKA RW 20 Digital Mixture, Induction Sealer LGYF- 2000BX, Forced Air Shel Large Lab Oven, Maxi Blender, 0.5 – 8.0 Qt, Stainless Steel Drum Pump, Manual Capsule Machine, Sizes 00 through 5, Tablet Press, D & B Pre-Compression Tooling, LABCONCO-Water Pro RO and PS DI Water System.