Strong chemistry based technology skills. Ability to create lasting intellectual Property with highly motivated Science Leaders. Expertise in analytical Chemistry and regulatory insights that help reach out to different Regulatory regions facilitating easy entry to markets in time. Highly trained team can execute the process quickly and efficiently on large scale, making sure that all of the operations are carried out in a way that meets the requirements and expectations of regulatory agencies.
At ArkGen leadership is key component in creating knowledge, building strong intellectual base, cultivating an environment with values, with an insight of market dynamics.
ArkGen team is highly qualified with doctorate degree in synthetic organic chemistry and have got unique expertise in DMAIC (Define, Measure, Analyse, Improve and Control) Process in realizing cost-competitive and quality products.
ArkGen team executes the process quickly and efficiently on large scale making sure that all of the operations are carried out in a way that meets the requirements and expectations of regulatory agencies.
ArkGen team has cumulative experience of 40+ years to ensure the quality of drug products by carefully monitoring drug manufacturing’ process from developmental stage to finished products with its Current Good Manufacturing Practice (CGMP) regulations.
ArkGen team, has in-depth knowledge on the patent mapping, infringement / enforceability and Para IV filings to drive the development of non-infringing process.
ArkGen has got 400+ products in its inventory and team has strong skills in synthesis and characterization of impurity standards, metabolites and duterated analogues.
ArkGen pharma has given top priority in selecting its team members who has vast experience in instrumentation and interpretation skills with state of art knowledge in the CGMP documentation.
Synthetic Chemistry or Design of Experiments
Technology-Scale-Up and Bulk Production Skills
Regulatory: Control Skills
Intellectual Property Rights (IPR)
Instrumental Analysis and Interpretation Skills