• API
• human medicinal products
• veterinary products
• biotech products
• herbal products
• medical devices
• food supplements

• Planning and fulfilling of the development process within 3 stage process (theoretical, lab-scale, pilot-to- full scale)
• Formulation development (solid oral dosage forms, parenteral dosage forms, semi-solid dosage forms, API of herbal origin etc.)
• Product quality assurance system based on risk analysis evaluation (control points and parameters for controlling)
• Stability studies
• Process development and scale-up
• Technology transfers
• Analytical Development Services:
  - Analytical Method Validation (Verification)
  - Bioequivalence Testing
  - Pharmaceutical Raw Material Testing Services
  - Method Development

• Dossier Development as per CTD or ACTD Format
• Development and updating of DMF for APIs of synthetic, semi-synthetic and herbal origin
• Сreating registration dossier for variations (including type II)
• Audit and Evaluation of a dossier before submission to Regulatory Authorities

• Clinical trial management (project planning, local Ethics and Regulatory Submissions, support of contracts, work with vendors, formation and maintenance of TMF)
• Feasibility, site selection, study start-up, interim and final close-out visits

• Marketing authorization strategy and deployment plan development
• Target product profile development (specification of requirements for product development and preparation of a registration dossier for the target market)
• Gap analysis of the registration dossier
• Compilation of a registration dossier and submission to the Regulatory Authority
• Managing registrations, registration renewals and variations processes with the Regulatory Authority
• Accompanying responses preparation to the comments of the Regulatory Authorities
• Product lifecycle management
• Supporting the WHO Prequalification procedure
• Marketing authorization transfer
• Medical texts writing

• Compliance with guidelines on GVP
• Services of a QPPV (24/7) with access to medical adviser
• Creation and support of the Pharmacovigilance system
• Management and reporting of adverse reactions to medicinal products
• Ongoing benefit-risk evaluation
• Preparation of Risk Management Systems and Risk minimization measures
• Audit of PhV system
  

• Project Statue preparation (Goals, budget, human resources, timeline, benefits plan)
• Providing managerial and coordination work within project (contract development, technology transfer) on the base of the efficient cost&time saving approach
• Interim project achievements report preparation on weekly/monthly basis
• Final project result report within budget/schedule/goals analysis

• Pharmacoeconomics calculation
• Target markets regulatory requirements assessment (global)
• Promo materials assessment
• Scientific and regulatory consultations
• Preparation of documents for inclusion of the drug in the national protocols of treatment
• Preparation and implementation of in-house trainings