Services

Other Regulatory Services RELATED PUNCHLINE WILL APPEAR HERE

Other Regulatory Services

  • 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