RegDev, Inc.
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RegDev, Inc. Details
RegDev, Inc provides services focused on meeting the unique needs of our multinational clients in the biopharmaceutical industry. This is achieved by our highly experienced team providing global wisdom and connections. Our team of highly experienced and committed consultants are dedicated to delivering quality services to our clients. All of our consultants are industry veterans including Health Authority veterans, such as ex-FDA and ex-MHRA officers. Under the leadership of our founder Sid Senroy, RegDev’s clients have grossed $100B+ worldwide with their safe and efficacious drugs currently on the market as well as 20+ successful NDA/BLA filings and inspections by global health authorities. RegDev is proud to have assisted in the optimal execution of clinical trials and implementation of best practices using our specialized RegDev Method. Services offered: -GxP (GCP, GMP, GLP, GVP, and GDP) Support -Gap Assessments -Audits and Inspection Readiness -Remediation -Risk-Based Assessments -Quality Systems Management -Vendor Qualification and Management -CAPA Support -Clinical Operations -Drug Safety and Pharmacovigilance -Regulatory Strategy -Regulatory CMC -Computer Systems Validation and Implementation -TMF -Training (ICH GCP and R2 Addendum, GxP, Inspection Readiness) -SOP Development and Training To learn more, email [email protected]. #biotechnology #pharmaceutical #lifesciences #biotech #drugdevelopment
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