Regulatory services

Dr.SSK Labs Pvt.Ltd. regulatory services include consulting, compliance, and lifecycle management to ensure that drugs and medical devices meet quality and regulatory standards.

Regulatory Affairs

Oversees the development, testing, manufacturing, marketing, and distribution of drugs, foods, and medical products

Regulatory Compliance

Ensures that companies adhere to regulatory guidelines and requirements

Pharmacovigilance

Monitors, reviews literature, and conducts audits to ensure drug safety and compliance

Post-approval life cycle management

Tracks regulations and prerequisites for a product’s launch

Gap analysis and remediation

Analyzes dossiers and prepares remediation plans

Regulatory intelligence

Prepares for inspections, understands trends and submission requirements, and conducts surveillance

CTD and eCTD services

Includes publishing and e-Submissions.

Technology transfer with documentation

Ensuring seamless knowledge transfer, regulatory compliance, and efficient scale-up of pharmaceutical processes.

Respiratory

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Regulatory services