Spark Pharma Regulatory Consultant

Varachha, Surat, Gujarat

We provide medical regulatory consultants. preparation and submission of regulatory documentation including: 1. Technical files2. Design dossiers regulatory and technical review and consulting. preparation and submission of registration for product applications. clinical trial applications. medical device vigilance and reporting systems. regulatory and manufacturing compliance. Strategic and regulatory planning. auditing of quality & regulatory system to ensure compliance with required quality systems & regulationsregulatory/quality gap analysis. interpretation of guidance documents and legislation. assistance with device labeling requirements. liaison with regulatory authorities. Provide medical device classification. Risk management (iso 14971)

We provide food supplement regulatory services. Product Evaluations Spark Pharma Regulatory Consultant advise whether your products are classed as a food supplement and provide advice on adjustments in order to comply. We inform companies of the exact status of grey area ingredients such as amino acids, botanicals, essential nutrients and enzymes. We also advise whether the product in fact a Medicine, a Traditional Herbal Product or a Medical Device. Nutrition and Health Claims We analyze nutrition and health claims and the Scientific Opinions of the Food Standards Agency to advise how to legally market products and build your strategy.Our services also include the following:1. Product Approval (Health Supplement & Proprietary Food)2. Health claim dossier3. Central License, State License & State Registration Labelling and Copy Reviews Spark Pharma Regulatory Consultant assess food supplement product labels and packaging copy to provide simple edited instruction documents for compliance with food supplement labelling legislation. Advertising and Marketing ReviewsSpark Pharma Regulatory Consultant appraises natural product websites and advertising literature to make sure it complies with Advertising Standards Authority. Novel Food Applications A novel food is defined as a food that does not have a significant history of consumption. Such foods require a pre-market safety assessment in the form of a Novel Food application or a simplified procedure for substantial equivalence foods. Spark Pharma Regulatory Consultant compiles novel food applications dossiers; covering history of use, intended purpose, nutritional value, composition, toxicological and nutritional data.

We provide herbal medicine registration services. preparation and review of traditional herbal registration dossiers. preparation of patient information leaflet (pil), writing, proof reading, and user testing: for compliance with labelling laws. registration of traditional herbal medicinesproduct rationale on scientific basis

o Conducting audits of cosmetic manufacturers to assure compliance with GMP guidelineso Reviewing cosmetic labeling for compliance with FDA requirements.o Evaluating the safety of cosmetic ingredients.o Preparing color additive petitions for submission to Regulatory Authority for approval.o Designing clinical studies to document safety of ingredients, and to substantiate label claims.o Serving as expert witnesses and providing testimony on litigation involving disputes over color/cosmetic regulatory matters.o Arranging and attending meetings with Agency officials on behalf of our clients.o Providing guidance on import procedures, import registration and assisting in obtaining clearance of products.o Providing management and employee training on color/cosmetic regulatory matters.o Providing recall advice and assistance as needed.

We provide artwork design. folding boxes / cartonspatient information leaflets (pil) / information for users (ifu)bookletslabelcarton blisterstubessachetsadhesive labelspouches and outsertsdiagrams or illustrationsbespoke symbols or pictogramsmedical devices

Fssai services: product approval: new product approval, existing product approval. Registration/licensing: conversion of existing license into fssai, renewal of registration/license, fresh registration/licenseso avail our services for obtaining fssai registration / license of proprietary food, dietary supplement & nutraceuticals.

We provide pharmaceutical regulatory consultants. 1preparation of registration dossiers for submission to various regulatory agencies all over the world (ectd, ctd, actd format & country specific requirements). drug master file (dmf) preparation & compilation for open and closed part. preclinical and clinical overviews writing through literature search / published studies / articles from journals from different sources. expert reports on quality , pre-clinical and clinical orphan drug application preparation and submission. prepare summary of product characteristic (smpc), pack insert, product rationale. assistance in response to queries for submission to the regulatory agencies. total development of product from lab scale to pilot plant scale to actual production scale for drug substance and drug product. prepare summary of product characteristic (smpc), pack insert, product rationale. periodic safety update report (psur) preparation. provide analytical support in analytical method development / validation, routine analyses of products by hplc/gc/ms etc. complete stability programme management service is provided as per ich guidelines/special requirements in a cgmp and glp compliant environment. monitoring and liaisoning with the cros for clinical and be studies. preparation of site master file

We provide pharmaceutical licensing services. Product permissionloan licensecertificate of pharmaceutical product (copp)free sales certificate

We provide pharmaceutical regulatory consultants. Product approval: new product approval, existing product approval. Registration/licensing: conversion of existing license into fssai, renewal of registration/license, fresh registration/licenseso avail our services for.obtaining fssai registration / license of proprietary food, dietary supplement & nutraceuticals

Product evaluationsspark pharma regulatory consultant advise whether your products are classed as a food supplement and provide advice on adjustments in order to comply. We inform companies of the exact status of grey area ingredients such as amino acids, botanicals, essential nutrients and enzymes. We also advise whether the product in fact a medicine, a traditional herbal product or a medical device. nutrition and health claimswe analyze nutrition and health claims and the scientific opinions of the food standards agency to advise how to legally market products and build your strategy. Our services also include the following: product approval (health supplement & proprietary food) health claim dossier central license, state license & state registration labelling and copy reviewsspark pharma regulatory consultant assess food supplement product labels and packaging copy to provide simple edited instruction documents for compliance with food supplement labelling legislation. advertising and marketing reviewsspark pharma regulatory consultant appraises natural product websites and advertising literature to make sure it complies with advertising standards authority. novel food applicationsa novel food is defined as a food that does not have a significant history of consumption. Such foods require a pre-market safety assessment in the form of a novel food application or a simplified procedure for substantial equivalence foods. Spark pharma regulatory consultant compiles novel food applications dossiers; covering history of use, intended purpose, nutritional value, composition, toxicological and nutritional data