- Regulatory Pathway Planning: Developing strategies for drug approval in different regions (India, U.S., EU, etc.), tailored to the product's classification (new drug, biosimilar, generic, etc.).
- Pre-Submission Consultations: Engaging with regulatory authorities like the CDSCO (India), FDA (U.S.), and EMA (EU) to seek guidance on submission expectations.
- Regulatory Roadmaps: Creating a comprehensive roadmap for meeting all regulatory milestones from preclinical development to post-market surveillance.
- New Drug Applications (NDA) : Assisting with the preparation and submission of NDAs for new drugs, ensuring compliance with requirements.
- Investigational New Drug (IND) Applications: Preparing IND submissions to initiate clinical trials, including all necessary preclinical and clinical data.
- Biologics License Application (BLA): Support for filing BLA for biologics, including documentation on manufacturing, clinical data, and quality control.
- Abbreviated New Drug Application (ANDA): Assisting in the submission of ANDA for generic drugs to obtain approval without clinical trials based on bioequivalence studies.
- GMP, GCP, GLP Audits: Conducting audits to ensure that companies adhere to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) as required by regulatory agencies.
- Internal Audits and Pre-Inspection Audits: Helping companies prepare for regulatory inspections through internal compliance checks.
- Corrective and Preventive Action (CAPA) Systems: Designing and implementing CAPA systems to address non-compliance issues and prevent future occurrences.
- Labeling Strategy: Ensuring that drug labeling complies with regulatory requirements, including accurate representation of dosage, usage, and safety warnings.
- Review of Promotional Materials: Reviewing and approving marketing and promotional materials for compliance with drug advertising laws.
- Regulatory Updates for Labeling: Keeping up with changes in labeling requirements and ensuring that packaging and inserts are updated accordingly.
- Risk Assessment in Submissions: Identifying potential risks in regulatory submissions and developing strategies to mitigate them.
- Regulatory Risk Mitigation Plans: Helping companies prepare for potential regulatory challenges and inspections, including guidance on how to address deficiencies.
- Post-Marketing Surveillance (PMS): Setting up PMS programs to monitor drug safety and efficacy after market approval.
- Adverse Event Reporting: Implementing systems for reporting adverse events (pharmacovigilance) to regulatory authorities, including setting up processes for Pharmacovigilance Program of India (PvPI) compliance.
- Annual Reports and Renewals: Assisting with annual reporting to regulatory bodies and managing drug license renewals, including documentation of any post-market studies or updates.
- Training Programs: Offering training for employees on regulatory requirements (GMP, GCP, GLP), submission processes, and compliance best practices.
- Capacity Building for Regulatory Affairs Teams: Helping organizations build strong internal regulatory teams through mentorship and ongoing training on global regulatory standards.
- Inspection Readiness: Preparing companies for regulatory inspections, including mock inspections and gap analysis to identify areas of improvement.
- Response to Inspection Findings: Assisting with the preparation of responses to regulatory findings, such as Form 483 (FDA) or CDSCO inspection reports, and developing corrective action plans.
- Handling Regulatory Queries: Supporting companies in responding to queries from regulatory bodies during the approval process or post-approval phases.
- Monitoring Regulatory Changes: Keeping up with evolving regulations in India, the U.S., Europe, and other markets, and advising companies on how these changes affect their compliance status.
- Impact Analysis: Assessing the impact of new regulatory policies on a company’s operations, product approval timelines, or market access strategies.
- Global Regulatory Submissions: Supporting multinational companies in navigating the regulatory requirements for entering different markets, including regional differences in approval processes.
- Harmonization Strategies: Helping companies streamline regulatory submissions for multiple markets by leveraging common data packages and regulatory pathways, such as those under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- Lifecycle Management Strategy: Assisting companies in managing the regulatory aspects of a drug throughout its lifecycle, including product modifications, line extensions, and new indications.
- Post-Approval Variations: Handling regulatory submissions for post-approval changes to a product, such as manufacturing site changes, formulation updates, or new dosage forms.
