Dossier Consultancy Services

Spectro Analytical Labs Ltd. assists its clients in technical Dossier & Common Technical Document (CTD) preparation. The Dossiers & CTD has now become mandatory for market authorization in order to get products registered. We support our valued clients for preparation and evaluation of the Technical Documentation & Design Dossier according to the appropriate guidelines. We provide consultancy services to pharmaceutical & related Industries to meet the challenges faced in the Market with experience staff & excellent regulatory solutions. We at Spectro help you seek approval for drug/food product in almost all countries worldwide. Spectro helps you gain approval from concerned agency in order to regulate your Food and Beverage Product globally by meeting the necessary guidelines as per each & every country. Our services also include Compilation of Drug Master File (DMF) containing complete information on API including its chemistry, stability, purity, impurity profile, packaging and cGMP status. Spectro provides facility for dossier registrations which includes REACH, Food & Drugs etc..

Spectro Scope of Activities Involves:-

  • Performing studies on the product of interest
  • Analysis of Data
  • Dossier writing for registering the product as per the specific format & guidelines
  • Carrying out validation & stability studies as & when required by the client
  • Reports Preparation & submissio
  • Post Submission support

Dossiers for Food, Nutritional Products & Nutraceuticals:

Keeping the gaining momentum of Food, Nutritional Products & Nutraceuticals in India, FSSAI has been streamlining the laws related to food and food technology in terms of safety, nutritional value, chronic disease preventing properties and health benefits. The provisions include quality control of food imported into the country; risk assessment etc. The steps involved in the approval process of nutraceutical ingredients and products before they are placed in the market include preparation of the product dossier and its due submission to FSSAI. Spectro has an expert team which deals exclusively in preparation of Dossiers for Food & Nutritional Products including Nutraceuticals.