We offer services for research and development of pharmaceutical products, preparation of registration dossiers, clinical trials, products registration, pharmacovigilance, project management and others
Our services apply to:
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API
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human medicinal products
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veterinary products
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biotech products
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herbal products
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medical devices
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food supplements
Research and Development
✓ 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:
• Method Development
• Analytical Method Validation (Verification)
• Bioequivalence Testing
• Pharmaceutical Raw Material Testing Services
Regulatory Dossier Writing
✓ 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 Trials
✓ 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
Regulatory Affairs
✓ 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
Pharmacovigilance
✓ 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 Management
✓ 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
Consultations and other services
✓ 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