Dipak Doshi Email & Phone Number

Protocol Link offers an even balance of expertise and experience. We are driven by providing the best solutions to help our clients meet their business goals. With more than 1,000 projects completed, representing engagements in the US, Australia, Belgium, China, Denmark, France, Finland, Germany, India, Italy, Japan, Mexico, The Netherlands, Norway, Puerto Rico, Romania, Switzerland, Spain, and South Korea, Protocol Link has built a strong worldwide presence. Protocol Link's niche services include Regulatory Affairs, GMP Compliance, QA/QMS, Validation, and Technical Services for liquid-solid dosage pharmaceuticals, sterile (SVP and LVP) product technologies, medical devices and diagnostics platforms, biologics and biotechnology products, and API-bulk pharmaceutical drug substances.Protocol Link has expertise in cGMP compliance management, gap analysis, FDA liaison, preparations for FDA inspection readiness, regulatory submissions, compliance audits and assessments, due diligence reviews, vendor audits, CAPA investigations, computer and software system validation, validation master planning, facilities management, critical systems, equipment, processes, technology transfer, process scale-up, cGMP documentation, master batch records, SOPs, specifications, change control, and personnel training.Specialties: Regulatory Affairs, cGMP Compliance, Quality Assurance, Validation

Listed skills include Gmp, Pharmaceutical Industry, Validation, Fda, and 43 others.