I N T E R V I E W
What kind of services are you providing to the biopharma and drug discovery companies in India , Asia , and globally ?
Drug manufacturers must demonstrate that production equipment is not reactive , additive , or absorptive so as to affect the safety , identity , strength , quality or purity of the drug product . Our services support the biopharma manufacturers around the globe who manufacture their products using conventional stainless-steel equipment to hybrid systems to the completely single-use-technologies as product contact parts in the final fill-finish . We ensure that our services are in
compliance with the latest regulations like European Annex 1 that was effective in 2023 and the United States Pharmacopoeia Chapters < 665 > and < 1665 > that will be effective in 2025 .
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We partner with the biopharma manufacturers to support them in managing their process risks and ensure regulatory compliance by coming up with a robust compliant and effective risk-based validation strategy to demonstrate that
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BioVoiceNews | May / June 2024