Support
Centre for Public Health and Food Safety (CPHFS) is a registered non-profit organization, setup and run by a team of dedicated and passionate professionals from Food, Drugs, Cosmetic ,Medical device, Pharma, Healthcare, Environment, Education, Legal, Information Technology, banking, technology backgrounds with rich experience from corporate and government segments . We provide advocacy services on different areas and made fund utilize for achievement of aims and objectives of Centre for Public Health and Food Safety.
Drugs, Cosmetic & Medical Device
- New Drug Approval (NDA).
- Subsequent New Drug Approval (SND).
- BE NOC for export.
- Special code/Neutral Code for export.
- BE Studies.
- Form 29 for Test Batch.
- Toxicity Studies.
- Clinical Trials.
- Manufacturing & Wholesale License.
- Test License.
- Export NOC & Dual NOC/li>
- Free Sales Certificate
- Formulation Development & Optimization.
- Approval of Drugs, Cosmetic, Medical device, Diagnostic Kit etc. from Central Drugs Standard Control Organization ( CDSCO).
- Preparation of TTDs / DMFs / Technical Documents / dossiers / Techpack etc. for EU and Non EU countries.
- Facilitation of Plant setup and regulatory & legal compliances.
FOOD
- FSSAI Registration Certificate.
- FSSAI License- State & Central License (Importer, Manufacturer, Marketer, Distributor, Storage, transporter, Re-Packer, Relabelar and Exporter etc.).
- Modification/Renewal in License.
- Annual Return.
- Advisory Services for FSSAI (Licensing & Registration) Regulations, Compliance and Inspection.
- Formulation designing & development.
- Label artwork designing, legal validation & Claim Compliance.
- Imports clearance.
- Importer and Exporter (IEC) Certificate.
- Approval of Non –Specified food ingredients/ products.
- Legal assistance- reply of notices, handling Court matters. on- time response to FBO , Technical representation, Scientific based legal assistance and Adjudication support.
- Ingredient scrutinization and RDA comparison Analysis.
- Product Testing from NABL Labs and testing parameter support.
- Clinical trials for Claim Support.
- Product certification and licensing for Proprietary food, Food supplement, Nutraceuticals, Infant formula, Food for special medical purpose on the basis of risk assessment and FSSAI regulatory norms.
- Facilitation of Plant setup and regulatory & legal compliances.
Regulatory & Approval
- Advise and assist on regulatory environment impacting client's business.
- Review/ drafting of documentation from regulatory standpoint.
- Representations before Government authorities and assistance in obtaining regulatory approvals/ clarifications from various regulatory authorities (including MCA/RBI/SEBI/Central Govt.).
- Assisting in Regulatory Compliance/ Health Check Review.
- Assistance in compounding & similar proceedings with various regulators and advice during regulatory investigations.
- Registration under The Shop and Establishment Act, Legal Metrology Act & UAM for MSME.
Training
- Food Safety Supervisor (Importer, Manufacturer/ Processer, Marketer, Retailer/Distributor, Storage, transporter, Re-Packer/Relabelar, Transporter and Exporter etc.)
- Good Manufacturing Practice (GMP).
- Good laboratory practice (GLP ).
- Good Hygienic Practices (GHPs) & Hazard Analysis and Critical Control Points (HACCP).
- Food Safety and Management System ( FSMS).
- Quality audits and inspections – Planning, Procedures, Report writing.
- Quality Standards of Drugs, Cosmetic and Medical Devices.
- International regulatory framework & Investigation techniques.
- Women and child empowerment.
- Environment protection and enhancement.
- Adult Education and Skill Development.
- Goods and Services Tax ( GST).
- Implementation & Auditing of ISO-22000, EDQM, USFDA,TGA, QMS, WHO: GMP certification, KFDA, COFEPRIS, USP Certification and ISO : 9001 : 2015 / 14001:2015 .
- Competency Based Development Courses.
- Business and Strategy Development Training course.
