Legal and Regulatory Services

Legal and Regulatory Services

Herbal Consultants can help you in the legal and regulatory affairs for India and International locations.

Dietary food Supplements & Natural Products:
We offer regulatory consulting for companies involved in the production, packaging, labelling or holding of dietary nutritional supplements for distribution in India and Internationally. Our services in this area include:

  • Manufacturing unit layout approvals.
  • Manufacturing License.
  • GMP Certification.
  • ISO, NSF, Kosher, Halal, etc certifications.
  • Individual product licenses.
  • cGMP certification – Indian FDA, FSSAI, USFDA-GMP, WHO-GMP, any other country specific cGMP.
  • New Product DCGI approvals.
  • FTC, FDA, FSSAI and DSHEA compliance.
  • Product formula review and classification.
  • Guidance on all aspects of labeling, marketing and advertising.
  • Development of the Supplement Facts box.
  • Structure/Function claim development and substantiation.
  • Guidance on New Dietary Ingredients (NDI) and Old Dietary Ingredients (ODI).
  • Filing of FDA, FSSAI, and International notifications.
  • Consulting on GRAS classification and development.
  • Quality assurance and product testing review.
  • Guidance on Adverse Event Reporting (AERs).
  • Ongoing liaison with government agencies and client representation.

Food Labeling Requirements & Regulatory Affairs
Complying with food labeling laws and regulations can be a challenge given the many gray areas in the regulations and guidelines. Our services in this area include:

  • Classification and confirmation of food status (e.g. food versus drug, conventional food versus novel food).
  • Preparation of food labels and reviews for compliance.
  • Preparation of nutrition facts tables.
  • Preparation of Novel Food Notifications.
  • Preparation of GRAS Notifications.
  • Interim and Temporary Market Authorization (TMA)
  • Verification of compliance of health and nutrition claims.

Failure to comply with the food regulations can result in costly future corrective actions, and even possible recalls. We can not only help to ensure your food products are compliant, but can also suggest ways in which your food products can be placed on the market with a competitive advantage.

Cosmetic Regulatory Affairs
While the regulations governing cosmetics are relatively straightforward there are potential pitfalls, particularly in the areas of proper classification and appropriate claims. Herbal Consultants experience, together with our ongoing relationships with cosmetic trade associations and government agencies, keeps us ahead of the curve with respect to any cosmetic regulatory affairs. Our services in this area include:

  • Cosmetic ingredient reviews
  • Cosmetic label reviews
  • Cosmetic claim and advertising reviews
  • Cosmetic Notification Forms
  • Advice on cosmetic GMPs

OTC Regulatory Affairs
Herbal Consultant’s expertise is also to assist companies in obtaining licenses to sell their drug products over the counter (OTC). Our services in this area include:

  • Drug classification (labeling standard versus new drug, prescription versus non-prescription).
  • Preparation of Drug Identification Number (DIN) applications.
  • Responding to Clarifaxes.
  • Preparation of compliant draft labels.
  • Filing notifications and amendments.
  • Filing Annual Drug Notifications.

Government cost recovery fees for drug applications can be expensive. You can ensure your application is right the first time with help from Herbal Consultants.

Scientific Writing
Our services in the area of scientific writing include a wide portfolio. We can create the following for you:

  • Scientific publications and reviews in national and international scientific journals.
  • Brochures for scientific and marketing purposes.
  • Expert reports.
  • Registration dossiers (CTD).
  • Monographs.
  • Product brochures.
  • Books and multimedia presentations.
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