Submissions of Dossiers of US Markets(ANDA) and Europe markets(CTD)
Well versed with Drug Master File(DMF's)
Handling of queries due to New product or Variations from Different Regulatory Guidlines
Interaction with Cross functions like ADL,F&D,API
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Claris Lifesciences Limited
www.clarislifesciences.com
Claris Lifesciences is an IPR driven international pharmaceutical company, in the business of manufacturing and marketing of high end injectables with focus on New Drug Delivery Systems for treatment of critical illnesses and diseases.
With emphasis on Quality, Technology & Innovation, Claris offers a range of niche technology Aqueous & Lipid emulsion injectable products across delivery systems such as bottles, vials, ampoules, non-PVC/PVC bags . The company's strength lies in its know-how and expertise in manufacturing and marketing injectable products.
Driven by a team of scientists, pharmaceutical experts and management professionals, Claris is powered by a combination of Vision, R&D capabilities, Technological know-how, International standards and Manufacturing expertise , an expanded Proprietary Marketing Network and Ambition to be one of the world's leading and most admired pharmaceutical companies in the global generics space.
The company's range of products and delivery systems extends across Enteral and Parenteral Nutrition, Anaesthesia, Blood Products and Plasma Volume Expanders, Anti-infectives, Dialysis and Transplant, Oncology & Infusion Therapy.
Claris enjoys Market Leadership in India. Globally, the company operates in more than 76 countries, through its subsidiaries, offices and marketing/distribution network, and a diverse customer profile covering institutions, large corporate hospitals and international aid agencies.