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Regulatory and pricing
Selection of raw material suppliers and contract manufacturers to develop and produce pharmaceutical compounds.
Comprehensive services, including training, updating of your Drug Master Files (D.M.F.) and Certificates of Suitability (C.O.S.).
Development and implementation of a rational regulatory strategy, in compliance with E.C requirements and international (ICH) guidelines.
Compilation, review, submission and follow-up of the regulatory application.
Market assessment and competition review.
Negotiation and optimization of the reimbursement price with European Government Agencies.
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Licensing in
Identification of the needs.
Research of the available products matching your criteria.
Coordination, follow up and assistance in the negotiation until the signature.
Licensing out
Review of the existing scientific Due Diligence.
Evaluation of development and registration costs.
Market opportunity, assessment and evaluation (benefiting from the knowledge and the understanding of the corresponding markets).
Research of partners: licensors and distributors.
Coordination of the contacts, organization of the meetings, redaction of the contracts.
Transfer of technologies.
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Development of pharmaceutical drugs
Pharmaceutical,
Preformulation and formulation of drug specific dosage forms
Stability assessment
GMP manufacturing
Chemical and analytical services
Preclinical
Toxicology and biological testing
Pharmacokinetics and Metabolism
Synopsis
Clinical
Protocols compilation
Phases II, III, and IV project management
Clinical and statistics reports
Good clinical practices
Marketing authorization
Experts reports and filling through EMEA, EU National Drug Agencies and FDA.
These specialised development projects are sub-contracted from conception to completion
to a combined experience of formulation scientists, pharmacologists, analytical and medical team, under IDL' s coordination and management.
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