Services

Kaf Innova Pharma is one of the few Bulgarian consulting companies offering services in the field of the pharmaceutical industry. Nowadays, Kaf Innova Pharma offer projects, consultations and analysis in the following fields: medicinal products, nutritional supplements, good manufacturing practise (GMP) and regulatory affairs.

Medicinal Products

medical products

  • Programmes and strategies for the development and market introduction of new medicinal products - specific market segments for products characterizing with small amount of packages but with a high value or with products without competition on our market;
  • Suggestions for the development of generic equivalent products, “block busters” on the market in the respective therapeutic field;
  • Suggestions for the development of new brand medicinal products- “Adding Value” ОТС based on the scientific achievements and marketing - analgesics-antipyretics- N02B; combined products for the treatment of cold and flu (RO5X); products for the treatment of inflammations in the oral cavity and throat (R02A или A01A); antihistamines (R06A) and others;
  • Development of products considering the manufacturer conditions and the preparation of a full registration dossier CTD;
  • Development of original products on the basis of “oral drug delivery” technologies:
    • Technologies improving the solubility of sparingly or low soluble drugs (Solubility-Enhancing technologies)- traditional methods and new mechanisms, liquisolid compact technology;
    • Modified-release Drug Delivery Systems
    • Oral dispersible tablets and granules;
    • Technologies masking the taste of active ingredients
    • Liquid and Emulsion Drug Delivery System;
    • Self Emulsifying Drug Delivery Systems (SEDDS), Self Micro-Emulsifying Drug Delivery Systems (SMEDDS), Solid SMEDDS, Nanoemulsions;
    • Mucoadhesive Drug Delivery systems;
  • Solution of problems with manufacturing products:
    • Problems related with the stability and shelf life of products;
    • Problems with dissolution test;
    • Problems with the pharmaceutical tests: hygroscopicity, hardness, friability;
    • Problems of the new drug molecules in the pharmaceutical development, non-standard technological approaches;
  • Availability of ready dossiers in CTD format of medicinal products, original compositions: ibuprofen and combinations, paracetamol and combinations, diclofenac, metamizole sodium, acetylsalicylic acid, combined products for the treatment of colds and flue- sachets, tablets, chewable tablets, capsules, oral drops and syrups, combined products (original) for sore throat- compressed lozenges on the basis of chlorhexidine digluconate, benzocaine, inhibitors rhinovirus, original mucoadhesive tablets, clopidogrel 75 mg film-coated tablets, piracetam, vinpocetin, levocetirizine dihydrochloride, loratadine, аcetylcysteine, herbal products, effervescent tablets, skin care, dental and galenic products.

Nutritional Supplements

medical products

  • Programmes and strategies for the development and market introduction of new nutritional supplements based on the following concepts:
    • Development of new compositions of nutritional supplements with the inclusion of ingredients enhancing the permeability and bioavailability of active ingredients based on proofed published scientific research or own research;
    • Inclusion of bioenhancing substances in nutritional supplements which are leading on the Bulgarian market in its respective application group: vitamins, nervous system, stress, insomnia, immune system, brain functions, reduced potency (aphrodisiac) and others;
    • Optimization of the compositions in view of pharmacology and synergism;
    • ncreasing the bioavailability of phytoproducts with NEW DRUG DELIVERY SYSTEMS - liposomes, micelles, nanoparticles, nanoemulsions, microsphere or other complexes.
  • Suggestions for the development of new nutritional supplements and dosage forms which are not present on the Bulgarian market;
  • Development of technology and documentation for nutritional supplements;
  • Organization of the production of nutritional supplements on well-established manufacturing site;
  • Solution of problems with produced nutritional supplements:
    • Problems related with the stability and shelf-life of the product;
    • Problems connected with the hygroscopicity of herbal extracts;
  • Availability of prepared documentation, original compositions on the basis of ascorbic acid, vitamins B, benfotiamine, gingko biloba, echinacea, hawthorn, valerian, peppermint, saw palmetto, curcumin, thyme, birch leaf.

Good Manufacturing Practise

medical products

  • Development and introduction of a whole GMP system (Good Manufacturing Practice);
  • Analysis of existing GMP systems and their development and improvement according to the latest requirements of the European Union and PIC convention;
  • Development of separate elements and procedures of GMP: process validation, cleaning, analytical methods, equipment and installation qualification, HVAC, installation for purified water;
  • Site master file preparation;
  • Development and introduction of the system of Good Distribution practice (GDP) according to the Europena requirements;
  • Training on the quality systems;
  • Development of preliminary projects for new pharmaceutical manufacturing and GMP evaluation.

Regulatory Affairs

medical products

  • Preparation of registration dossiers for pharmaceutical products in CTD format;
  • Preparation of expert reports;
  • Patent search and review for a pharmaceutical product and the patent status;
  • Marketing research for pharmaceutical products.