Audit Programs
Viglya conducts pharmacovigilance audits as well as helps clients prepare for third-party pharmacovigilance audits and regulatory inspections to ensure their efficiency and success. Viglya also guides clients in the development of Corrective and Preventive Action Plans (CAPAs) derived from audit and inspection findings.
Regulatory Affairs
Viglya helps clients develop regulatory strategies that focus on discovering and rapidly building scientific evidence to support the safety and efficacy of compounds. We provide strategic guidance in marketing authorization applications (MAAs), clinical (efficacy and safety) summaries, overviews, and labeling development.
Drug Development Strategy
We assist in identifying and addressing critical path issues that could delay development timelines, and we help define the hurdles to registration.
promoting science, honoring life
Viglya is a strategic consulting firm specialized in providing regulatory affairs and pharmacovigilance services for drug development, product registration, and life cycle management to the bio- and pharmaceutical industries.
Audit Programs
Viglya conducts pharmacovigilance audits as well as helps clients prepare for third-party pharmacovigilance audits and regulatory inspections to ensure their efficiency and success. Viglya also guides clients in the development of Corrective and Preventive Action Plans (CAPAs) derived from audit and inspection findings.
Regulatory Affairs
Viglya helps clients develop regulatory strategies that focus on discovering and rapidly building scientific evidence to support the safety and efficacy of compounds. We provide strategic guidance in marketing authorization applications (MAAs), clinical (efficacy and safety) summaries, overviews, and labeling development.
Drug Development Strategy
We assist in identifying and addressing critical path issues that could delay development timelines, and we help define the hurdles to registration.
promoting science, honoring life
Viglya is a strategic consulting firm specialized in providing regulatory affairs and pharmacovigilance services for drug development, product registration, and life cycle management to the bio- and pharmaceutical industries.
