VALIDATION SERVICES
Based on the rigorous US FDA Process Validation (2011) guidance for drug substance, drug product, biologics, vaccines, drug-device combination and medical devices.
Validation Services:
Each NDA/IND/BLA must include a full description of the manufacturing process, including analytical procedures that demonstrate Each NDA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product. the manufactured product meets prescribed standards of identity, quality, safety, purity, and potency. As technology increases, electronic batch records and electronic submission go hand in hand.
FDA Validation 2011
3 step process validation
VBK Pharma provides world class validation services which operate under global regulatory and safety standards. We work on cost-effective development and regulatory approval tapping globally competitive infrastructure and technology by an efficient team of data scientists.
With our expertise in formulating innovative and affordable dosage forms, we have embarked the path of going global by custom regulatory filing for reputed clients to various regulated markets across the globe.
- Strategic, global approach to regulatory planning and product development
- Global network of regulatory affairs experts with local knowledge
- Expertise in a wide range of therapeutic categories
- Proven track record of success with regulatory approvals with country specific health authorities
- Coordinated and focused compliance throughout the product lifecycle
Regulatory Filing in e-CTD format (Electronic Common Technical Document) to major regulatory and health authorities.
- USFDA
- EUGMP
- TGA
- PMDA
- KFDA
Dossier Authoring Services
Regulatory submission CMC writing including
- Investigational new drug applications (e.g., IND / INPD / CTA)
- Marketing authorization applications (e.g., NDA / MAA / NDS)
- Generic drug applications (e.g., ANDA / ANDS)
- Biologics license applications (e.g., BLA)
- Drug Master Files
- Global expansion filing support documents for ROW submissions
- Lifecycle submissions such as variations (e.g., CBE-0 / CBE-30 / PAS / sANDS), annual reports, renewals
Validation Support and Advice
- Define validation requirements and recommendations for new products,
- Validation strategies for product life cycle management and post-approval changes
- Regulatory review of QbD (Quality by Design) / QbR (Question based Review)
- Module 3 Gap assessment (product development and existing application)
- Module 3 pre-submission dossier review
Regulatory Publishing
Full publishing services available for FDA, EU and MHRA and many other international Health Authorities
- eCTD and non-eCTD electronic submissions
- Collation and compilation of complete dossiers Module 1 through 5
- Submission to Health Authorities via electronic gateways
Health Authority Meetings
Prepare correspondence documents and participate in pivotal meetings with health authorities for development projects and life cycle management across the product development timeline.
Clinical Support and Clinical Labelling
- Labeling assistance for clinical trial material (test and reference)
- Regulatory label review for US, EU, Canada, Australia, Asia Pacific and Latin America
- Translation and back-translation coordination
Quality Management Systems
- Conforming to the international standards,
- Use of Best-in-Class technologies
- Implemeting roboust Quality Management System by contious education and training,
- Consistently meeting appropriate technical, regulatory and legal requirements.
Contact Our Experts
For all your healthcare products contact our expert team members providing complete CMC [Chemistry Manufacturing and Quality Control] technical support.