Global Pharmaceutical & Biotech Regulatory Consulting
Skibo Regulatory Consulting
Pharmaceutical Regulatory Affairs Expertise for Product Registration and Lifecycle Management
Experience
- FDA
- EMA
- Health Canada
- PMDA
- ANVISA
- Emerging Markets
Products and Industries Supported
- Small Molecule Products
- Biotechnology Products
- API
- Contract Manufacturing Organizations
- Combination Products
I am PHARMA, the Smart Regulatory Cat.
This is what we can do for you.
Regulatory Support
We offer using our skills and experience to make a positive difference toward your company’s success and global presence by supporting introduction of your products into the new markets and ensuring compliance throughout product lifecycle and throughout product supply chain
CMC
Experience with small molecules, biologics, (vaccines, allergens, blood product) and combination products; experience with different dosage forms and routes of administration, including sterile injectables; experience with human and veterinary medicinal products
GMP and Audits
Mock FDA GMP audits, pre-approval readiness, GDP and PDMA compliance, REMS, Medical Information management. IRCA trained GMP Lead Auditor
Training
Offer wide range of customized training programs on US, EU and Emerging Markets pharmaceutical law and cultural sensitivities, global GMP requirements, and modern QMS design
About Us
Skibo Regulatory Consulting specializes in the pharmaceutical industry regulatory support.
We have global expertise in the US, EU, and emerging markets with multi-lingual capabilities in English, Spanish, and Russian.
Luba Skibo
President/CEO/Principal Consultant
Contact
Email: Skibo.SRC@gmail.com
Phone: (828) 569-0840 | (404) 431-0613
Regulatory Support
Submissions
- Compilation of new NDA, BLA, MAA, NADA — Submission Lead or part of the team
- Lead, preparation, or review of Quality Module for new product applications
- Preparation of INDs and CTAs
- Meeting requests and preparation of Briefing Packages
- Audit of new product applications supporting documentation
- Preparation of Supplements and Variations for major post approval changes
Strategic Advice
- Assessment of regulatory needs and design of appropriate Regulatory Affairs team
- Training on Pharmaceutical Law and applicable sections of Regulation for all functions and areas of business
- Quality and Regulatory support for Due Diligence activities
- Regulatory assessment of new business opportunities
- Gap analysis of Regulatory Affairs procedures
- Global regulatory strategy and modification of the Dossier
- BOD and Executive Management strategy review
Regulatory Support
- Audit of Regulatory Affairs files for compliance with applicable regulations
- Audit of Product Complaints and Adverse Events management processes
- Audit and gap assessment of State licenses management practices
- Review of promotional labeling activities and material
- US Agent
CMC
- Strategic CMC regulatory advice
- Type A, B, C meeting requests and Briefing Package review
- Major Post-approval changes
- Site transfers
- Change of suppliers
- Change Control system design and audit
- Preparation and Review of CMC Documentation:
- Investigational New Drug Applications (IND/CTA)
- New Drug Marketing Applications (NDA/BLA/MAA/NADA/NDS)
GMP and Audits
GMP Training
- Review of Regulatory Framework for drugs, biologics, and combination products — US, EU, Japan, Emerging Markets of interest
- GMP requirements — US, EU, Japan, Emerging Markets
- Quality Management Systems
- ICH Q8, Q9, Q10, Q11, Q12, Q13, Q14
- Periodic GMP training
Audits
- Mock FDA GMP audits
- Mock FDA PAI audits
- REMS programs
- Product Complaints and Adverse Events reporting systems
- QMS compliance and efficiency gap analysis
- Free samples distribution system
- Supply Chain Integrity
Training
All Training Available in English, Russian, and Spanish
Overview of US Pharmaceutical Law
- FDA Organizational Structure and Responsibilities
- Review of Legal Framework for drugs, biologics, and medical devices for human and veterinary medicinal products
- Current Regulatory Requirements and Recent Updates
- New Product Registration
- Clinical Trial Management
- GMP Requirements and Inspections
- Product Importation Requirements
- Labeling
- Role of Pharmacopoeias
- PICS
- MRAs and MOUs
- Review of ICH Guidelines
- CTD Structure and Management/CTD Quality Module
- Drug Integrity and Supply Chain Security
Overview of EU Pharmaceutical Law
- EMA Organizational Structure
- Review of Legal Framework for drugs, biologics, and medical devices
- Current Regulatory Requirements and Recent Updates
- EUDRALEX Structure
- Role of QP
Emerging Markets
- Review of Regulatory Climate and Pharmaceutical Law for markets of interest
- New product registration
- Clinical trials and IMP
- GMP requirements
- Inspections and quality considerations
- Product security
- Cultural Sensitivities and Diversity
- Logistics and practical implementation of the pharmaceutical law
- Brand Protection, IP, and Risk of Counterfeit Product
GMP and Quality Management Systems
- Overview of GMP regulations and legal requirements for markets of interest
- ICH Q1–Q14
- Documentation Management systems
- Deviations Management
- Human Error
- Continuous Improvement
- Review of Current Regulatory Enforcement Actions
Skibo Regulatory Consulting specializes in the pharmaceutical industry regulatory support.
We have global expertise in the US, EU, and emerging markets with multi-lingual capabilities in English, Spanish, and Russian.
Luba Skibo — President/CEO
Accomplished Regulatory Affairs executive with over 30 years of industry experience in the pharmaceutical/biotech industry. World-wide expert in leading global registrations, pre-approval mock audits, and conducting customized educational and training programs.
Specialized in US and EU pharmaceutical law and Emerging Markets regulatory framework and cultural sensitivities. Hands on experience includes global GMP requirements compliance assessment and regulatory CMC support for the new product applications.
Maria Mendieta
External Affairs Manager
Additional Consultants – team of industry experts is available depending on the project and client needs