Synthesis team has vast experience in handling various complex reactions ranging from Hydrogenations to Suzuki couplings with ease.

The chemistry capabilities of the team, covers the following areas:

• Chiral chemistry – chiral resolution, racemization, “enantioselective” synthesis

• Heterocyclic synthesis (benzimidazole, indole, isoxazole, etc.)

• Asymmetric oxidation and reduction

• Hydrogenation reactions

• Complex synthesis (selective reactions)

• Pyrophoric reactions

• Esterification of amino acids by using SOCl2.

• Tetrazole ring formation using Tributyl tin chloride and sodium azide.

• Friedel craft acylation.

• Reduction of aromatic nitro compound by using sulphur and NaOH.

• Reductive amination using triacetoxy sodium borohydride.

• Reduction of amide using POCl3, cyanuric chloride, Trifluoroacetic anhydride and T3P.

• Halo from reaction, Grignard reaction, Mannich reaction.

• Boc protection and deprotection.

• Amino acid synthesis.

• Reduction of carboxylic acid using NaBH4 and Iodine.

• Amide formation using DCC, EDC and HOBt.

• Oxidation of alcohol to aldehyde using Raney nickel, Pd/Carbon, Pd (OH)2 Catalyst in high pressure reactor.

• Cynation, nitration reactions and diazotization reactions.

• Isolation of Liquid APIs by column chromatography

• Enzymatic reactions with green chemistry approach.

Our Analytical team comprises 25 scientist and lab assistants with experience of handling all the latest analytical equipment. We also have a specialized team with vast experience in method development and validations, which supports the robustness of product specifications and compliances as per the requirement.

We at Enaltec’ IP team, bridges the gap between global patent laws and Research & Development. Blending with our deep domain expertise in Intellectual Property laws of US and India with cutting-edge technology and state-of-art processes, we bring advanced solutions for global IP management in R&D.

With realms of experience of patent laws of many different countries and with unique and robust combination of technical, legal and business acumen gives us a great advantage to come up with non-infringing strategies. With over 5 IP professionals including lawyers and patent agents, our core practice area include:

• Patent literature review

• Detailed Patent landscape for different countries

• Providing freedom to operate opinions

• Identifying Para-IV opportunity

• Providing design around strategies for branded products

• Licensing patent applications

• Providing business strategy

• Patent infringement analysis

• Patent invalidity search

Enaltec ensures adherence and compliance with all the applicable cGMP, ICH, GLP guidelines and regulatory requirements.

Key Functions

• Act as a liaison with regulatory agencies

• Preparation of organized and scientifically valid DMF submissions

• Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations, and laws

• Providing expertise and regulatory intelligence in translating regulatory requirements into practical workable plans

• Advising the companies on regulatory aspects and climate that would affect their proposed activities

• Evaluation of products and their ROS in line with regulatory guidelines

• USDMFs filed: 16

• CEP’s Filed: 2

• EUDMFs filed: 2