Regulatory Affairs and Regulatory Operations Services
Regulatory Strategy
Develop comprehensive regulatory strategies tailored to your specific projects, ensuring compliance and success.
Regulatory Submissions
Prepare and submit regulatory documents to health authorities for approvals, ensuring accuracy and adherence to guidelines.
IND and NDA Support
Assist with Investigational New Drug (IND) and New Drug Application (NDA) submissions, facilitating timely approvals.
Clinical Trial Applications (CTA)
Prepare and submit CTA dossiers, managing regulatory processes for smooth clinical trial initiation.
Marketing Authorization Applications (MAA)
Support MAA submissions, ensuring compliance with regional regulations.
Labeling and Package Inserts
Develop accurate and compliant labeling and package inserts for pharmaceutical products.
Post-Market Surveillance
Monitor safety and efficacy data post-approval, ensuring compliance with pharmacovigilance requirements.
Regulatory Compliance
Conduct audits and assessments to ensure adherence to regulatory standards and guidelines.
Health Authority Interactions
Coordinate and participate in meetings with health authorities to address queries and expedite approvals.
Lifecycle Management
Provide regulatory support throughout the product lifecycle, from development to post-marketing activities.
Electronic Submissions
Expertise in electronic Common Technical Document (eCTD) format for efficient and electronic submissions.