Follow-up with MOH till the registration documents are accepted and approval letter is issued
GMP Audit/Gap Analysis/Gap Closures services.
Guidance on Filings Variations/Amendment for the registered products
Guidance on Labeling and advertising of Medicinal Products
Expert reports on Regulatory Submissions
Guidance for Planning, Preparation and Delivery of regulatory submissions throughout the product's life cycle with regional perspective.
Guidance for Response Documents for health authority
Guidance on Briefing Documents for health authority
Liaison with Health Authorities on regulatory issues on routine and non-routine basis
Management of Complex Regulatory submissions
Preparation, Mainainence and delivery of Regulatory Operational Plans
Review of Annual Reports on Regulatory Compliance
Management of PIL, SPC and Physicians Training Materials
Change Control to avoid non compliance to the existing Marketing Authorizations
The Management of audits conducted by FDA/EDQM/MHRA and other Regulatory Authorities
Pre submission Review of Dossiers/CTD and amendments to the same.
Assistance for Product Withdrawals and Closure of Marketing Authorizations
Guidance on CFR Part 11, ISO 13485, CMDR, MDD , PAL, FMD ,ICH and other National and International Regulatory standards/laws/directives
Periodic appraisal of new regulations, standards, policies as issued by regulatory authorities that may impact the company business.
Guidance for organizing regulatory workshops for upgrading the knowledge of regulatory professionals employed at the site
Assistance for recruitment of top management regulatory staff as well as down line regulatory professionals
Assistance for Maintenance of Marketing Authorizations (Product Licenses) in chosen territories through regular updating
The Management of Marketing authorization under ANDA, MRP, CEP, NDA and national procedures
Advice and Training on new regulatory requirements
Responding to requests for technical support from Regional offices, Local distributors and Indenters.
Maintenance of databases relating to regulatory activities
Liaison with labeling group to generate appropriate packaging materials
Liaison with medical support group for Pharmacovigilance.
Guidance/support/training to Regulatory Affairs Team
Advise on the best approach to obtain regulatory approvals
Guidance on resolving departmental regulatory queries
Preparation of product development reports
Formal Review and Rectification of internal regulatory documents
Guidance to in-house CTD writers and Response team
Training and mentoring of junior regulatory writers
Updating the regulatory team with latest regulatory information
Negotiation and persuasion with drug regulatory agencies on technical matters
Assistance to young regulatory personnel for interpreting regulatory data/information and their implications on regulatory submissions
Development and execution of regulatory plans for complex regulatory projects involving genotoxic studies, extensive impurity profiling , characterization of polymorphs, BE studies on patients and Multicentre Clinical Trials
Review and evaluation of technical and scientific data required for submissions
Tracking the status of regulatory submissions
Regular regulatory input for product lifecycle planning
Assistance in developing and updating based upon evolving regulations.
Guidance on patent issues for ANDA submissions
Advise on regulatory structure and system of any particular region or country
Advise on risk-benefit aspects on new drug products
Advise on rational for drug combinations and new dosage forms
Overview of applications for product registrations
Advise on preclinical, clinical and manufacturing requirements for product development
Maintenance and renewal of manufacturing and marketing authorizations and product registrations
Assistance for the review of advertising and promotional activities
Electronic Submissions and updating of CTD documents
Contribution to the development and functioning of the crisis/ issue management program
Regulatory support for product recalls and recall communications
Solutions for resolving conflicts with regulatory bodies
Guidance for cultivating culture for regulatory compliances
Assistance for developing extensive network of mentors for regulatory guidance.
Guidance and active counseling of new recruits in regulatory department
Vendor audits and guidance for improving cGMP Compliance
Intelligent services for selecting innovative and practical methods to achieve regulatory solutions.
Assistance for the Management of Regulatory Compliance issues.
Participation in training programs for raising awareness of regulations applicable for designing, production, and marketing of pharmaceutical products
Reviewing and resolving Patient safety and/or regulatory noncompliance flagged items
Providing expertise on quality and regulatory issues raised by employees, management and customers
Representing the company on quality and regulatory matters before regulators
Complex data analysis and feed back for improvement on authorized products
Active support for verbal and written communications with FDA to resolve problems and queries
Audit for accuracy and scientific validity of the documents designed to meet current regulatory standards
Assistance for planning submissions and regulatory documents within agreed timelines
Mentoring the regulatory team on assigned projects
Assistance for identification and resolution of likely regulatory issues which may crop up over the time
Direct communication with Regulatory Authorities to expedite review and approval of submissions
Assistance for conducting scientific, regulatory legal or business research
Assistance in the archival process of all regulatory documents
Assistance for authenticating the product claims in advertising & promotional and labeling materials to ensure compliance with FDA regulations.
Active support for daily activities that support registrations, submissions and data analysis
Support for on-going corporate initiatives for regulatory compliance
Assistance to subsidiaries and distributors for regulatory compliance under FMD act
Assistance for Corrective & Preventative Actions to mitigate deficiency letters issued by FDA
Assistance on updating current worldwide regulatory requirements
Regulatory overview and guidance for new products in various stages of clinical development.
Development and implementation of global regulatory strategies to enhance the potential value of company assets.
Guidance on regulations across various geographic regions to maximizes probabilities of success for regulatory and ethical compliance
Liaison with regulatory team to develop and deliver effective strategic regulatory plans to support assigned projects
Management of global regulatory submissions with a high quality standards in alignment with corporate timelines and objectives for assigned compounds
Assistance for maintaining good liaison with global health authorities to ensure outcomes is consistent with program objectives
Guidance to regulatory team on latest regulatory/drug development issues so as to accelerate success in on going projects.
Interactions with regulatory authorities throughout the product registration lifecycle.
Assistance for tactful negotiation with regulatory authorities
Resolution of complex legal and regulatory matters clearly and effectively through clear and effective communication both with internal and external regulators.
Assistance to review/ analysis of initial project execution plans and/or corrective action plans to ensure compliance with new or existing laws and regulations
Building and maintenance of positive working relationships with regulators
Coordination with new business/sales/product development team to determine and comply with regulatory requirements
Management and resolution of consumer complaints
Training for CMC/Non Clinical/Clinical component of regulatory submissions
Training to the staff to handle multiple tasks and work under pressure
Advise on art and style for dealing with regulators/health authorities
Guidance on Product recalls and Adverse Events
Development and implementation of regulatory strategies aimed at gaining the earliest possible regulatory approvals
Establishment and maintenance of effective relationships with regulatory agencies
Company representation at public forums/conferences/seminars
Regulatory audit for conformance to EU, Canadian and FDA legislations and directives/guidance documents
Assistance to FDA for compliance investigations of drug products
The preparation, submission and timely approval of regulatory submissions
Support for proper archiving of regulatory SOPs, Documents ,Directives, Rules ,Acts, Approvals, Reviews, Submissions , Response Letters and Deficiency Letters
Advice on new drug development, new dosage forms development and new drug combinations.
Advise on designing protocols for BE studies, Clinical Trials and Non Clinical Studies
Advise on Impurity Profiling, Stability studies, Forced degradation studies, Analytical method development, Structure Elucidation, Excipients selection for the drug products
Advise on selection or reagents, solvents , starting material, intermediates and route of synthesis for new active substances
Guidance for Characterization API for Molecular Structure, Molecular Formula, Chirality, Polymorphism, Particle size, Solubility, Molecular form and Isomerism
Outsourcing of peer reviewed scientific articles on Non Clinical and Clinical aspects of the drug product
Drafting of overviews and summaries for CTD Module3,4 and 5
Redesigning of regulatory submissions to meet regional or national requirements
Scientific assessment and discussion on regulatory submissions specially on CTD Module 3
