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R&D

Famar’s talented scientific team is responsible for the flawless project execution, following a Quality by Design methodology and on the basis of good practices on Project Management. The R&D team’s principles are agility, versatility, can-do-attitude and commitment to delivery.

A value proposition that comprises the majority of pharmaceutical forms and regulatory status (Rx/OTC/Hybrid/Medical Devices) requested by Famar customers not just following EMA directives but FDA as well, and with a special focus on complex and HAPI products (OEB 3A).

A variety of commercially successful Consumer Care products are developed for Famar customers from the R&D center of excellence in Avlonas, with a focus on topical products.

The Analytical & Technical Service Department is in charge of accompanying the development of a new product at all stages, providing their expertise. From the early stages of physical-chemical characterization of the raw materials and the first prototypes to the development and validation of analytical methods, up to stability studies of finished products under ICH conditions.

Pharmaceutical Development

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Pharmaceutical Technology

  • Dry blending
  • Wet granulation: 1) Fluid Bed technologies; 2) High shear mixer
  • Extrusion granulation
  • Tablet compression
  • Capsule filling
  • Oral solutions/suspensions and emulsions
  • Semi-solid (cream, gel, ointment)
  • Sterile liquid injectable
  • Freeze-dried forms
  • Nasal sprays
  • Ophthalmics mono-dose or multi-dose preservative free
  • Formulations from immediate release to extended release/slow release formulations
  • Drug delivery formulations

Pre-formulation Development Services

Initial Risk Assessment:

  • Regulatory strategy and patent review.
  • Sourcing constraints
  • Quality by Design approach: preliminary design of Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA) to consider (drug substance and drug product)
  • API physical-chemical characterization (Particle Size Distribution, Enantiomeric forms, Polymorphism)
  • Excipients and packaging materials selection
  • Compatibility studies between API and excipients
  • Reverse engineering studies from existing products (where applicable)

Formulation Development Services

  • Formulation optimization and manufacturing of small batches for toxicological animal studies
  • Prototype generation and Design of Experiments (DoE)
  • Design of qualitative-quantitative formula. Definition of QTPP and CQA

Investigational Medicinal Product (IMP)

  • Manufacturing, labelling, packaging and release of IMP and placebo
  • Support on the preparation of the Investigational Medicinal Product Dossier (IMPD)

Industrialization Services

  • Manufacturing Process Development and Critical Process Parameters (CPP) Definition
  • Scientific and technical support on scale-up and engineering batches prior to full scale validation/registration batches to Third Manufacturers
  • Common Technical Dossier Compilation
  • Tech Transfer Out

Analytical Development Services

  • Analytical Method Development and Validation for Drug Substance and Drug Product
  • Analytical Method Development and Validation for Impurities, Related Substances and Preservatives
  • Extractable & Leachable studies
  • Forced degradation studies
  • Comparative In Vitro Dissolution Tests
  • In vitro – In vivo studies
  • Pre-stability and ICH stability studies
  • Analytical Method Development and Validation
  • Validation of microbiological methods
  • In vitro Release testing (IVRT)
  • ICH for zone II, IVa , IVb, US&EU, semi permeable products

Regulatory Services

  • Advice on regulatory registration strategy
  • Advice on CMC issues related development stages, manufacturing, quality control release testing,
  • Specifications and stability of the product
  • Nitrosamines risk assessment and ICH Q3D elemental impurities
  • Toxicology assessment of NCE, PDE
  • Advice on clinical issues related to manufacturing of IMP
  • Support on the preparation of the Common Technical Dossier (CTD)
  • Support on the preparation of the Investigational Medicinal Product Dossier (IMPD)
  • Preparation of answers to Regulatory Bodies

HPAPI Products

A dedicated area for non-GMP studies including High Potent APIs (HPAPI) suitable for:

  • Manufacturing of batches for toxicological studies in animal models
  • Formulation trials at lab scale
  • Design of experiments

A new dedicated area will be able to work under GMP conditions Safebridge 3A HPAPIs. It will be fully operational in 2021 and suitable for:

  • Manufacturing of Investigational Medicinal Product Phase I/II
  • Comparability studies
  • GMP DoEs in lab scale

Small Scale GMP Manufacture

A new GMP Pilot Plant will be fully operational in 2022 and suitable for:

  • Manufacturing of small commercial batches of Speciality Drugs
  • Manufacturing of Investigational Medicinal Products for Phase II/IIl (HiPo and Non HiPo)

Consumer Care Development

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Initiation of the Development

  • Customer Orientation, Key Concepts, Positioning
  • Product Categorization, Market Analysis

Formulation Development

  • Regulatory Requirements, Compliance, QTTP
  • Safety, Technical, Regulatory data documentation for raw materials
  • Formulation Development, Literature Research, Laboratory scale prototypes,
  • ICH Stability, Pre-Safety Toxicological Assessment, CQA
  • Packaging Development
  • Analytical Methods Development
  • Microbiological Methods Development
  • Development Report

Product Development

  • Definition of QTPP and CQA, Finalization of Formula
  • Process Optimization
  • GMP scale-up Production, Filling, ICH Stability, Compatibility
  • Clinical Studies, Safety Studies, Efficacy Studies
  • Technical File, PIF initiation

Planning & Production

  • Support on Industrial Validation Batch Production, Filling
  • Industrial Validation Batch ICH Stability
  • Analytical Method Validation
  • Microbiological Methods Validation

Product Release to Market

  • Technical File Support | PIF completion
  • Transfer Out activities (if applicable)