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Surat, Gujarat, India
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Medical Regulatory Consultants

We provide medical regulatory consultants.
preparation and submission of regulatory documentation including:

1. Technical files
2. 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 & regulations
regulatory/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)
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Food Supplement Regulatory Services

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 dossier
3. 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 Reviews
Spark 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.
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Herbal Medicine Registration Services

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 medicines
product rationale on scientific basis
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Cosmetic Regulatory Services

o Conducting audits of cosmetic manufacturers to assure compliance with GMP guidelines
o 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.
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Artwork Design

We provide artwork design.
folding boxes / cartons
patient information leaflets (pil) / information for users (ifu)
booklets
label
carton
blisters
tubes
sachets
adhesive labels
pouches and outserts
diagrams or illustrations
bespoke symbols or pictograms
medical devices
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Fssai Services

Fssai services:

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

We provide pharmaceutical licensing services.
Product permission
loan license
certificate of pharmaceutical product (copp)
free sales certificate
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Food Supplements

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:

product approval (health supplement & proprietary food)

health claim dossier

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 reviews
spark 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
View Complete Details
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  • Prakashkumar (Spark Pharma Regulatory Consultant)
  • A/ 248 Amrakung Shopping Centre, Yogichock, Varachha, Surat Gujarat. - 395006
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