Critical Healthcare, the multiple award winning, specialist provider of frontline medical and healthcare products and services to the global emergency services, has appointed Sai Manchikalapati as its new Regulatory Affairs Specialist.
Critical Healthcare ensures that healthcare professionals have all of the essential medical products they require to diagnose, resuscitate and rehabilitate a patient. The business has a diversity of customers that cover emergency services, armed forces and local authorities across eight European countries, with expansion into more planned.
An approved HSE and NHS supplier, Critical Healthcare works with emergency service providers across Ireland, UK, Germany, Denmark, Sweden, France, Spain and Poland, Critical Healthcare are also a key government supplier of the PPE and infection control items that have now become common-place in a ‘Covid-aware’ world.
The company recently invested over €500,000 in a new 30,000 sq. ft headquarters facility in Tullamore, County Offaly and as part of its expansion, Critical Healthcare has also increased its workforce to meet demand.
In his new role, Sai will take responsibility for the validation and verification of documents to ensure that Medical Devices placed on the market adhere to EU Regulation and EU Regulation Personal Protective Equipment. He will also manage the Internal Regulatory Portfolio covering both ISO and CE certification. Sai joins Critical Healthcare from medical device company, Cook Medical, where he worked in Regulatory Affairs.
Sai also brings a wealth of experience and understanding in conducting Phase I clinical Trials approvals as per ICH guidelines and Biotechnology product introduction and approvals across the Middle East, Asia, and Africa. He holds a master’s degree in Pharmaceutical Business and Technology.
Commenting on his new role, Sai said, “I’m delighted to join the Critical Healthcare team at such an unbelievable busy time as the company continues to be at the forefront of the fight against Covid-19. I am looking forward to contributing to the continued strategic success of the company and bringing my expertise in carrying out regulatory strategies.”
Dr. Anne Cusack, CEO of Critical Healthcare, added, “Sai is a very welcome addition to the Critical Healthcare team. As Regulatory Affairs Specialist, he is bringing a depth of knowledge and experience which will help take us to the next level of company development and, crucially, complements the existing team and client base perfectly.”
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