Services for Drugs and APIs
Registration of Generic, Similar, New and Innovative Medicines - Preparation, review and submission of the technical dossier to the local regulatory agency
Registration of Active Pharmaceutical Ingredients - Preparation, review and submission of the technical dossier to the local regulatory agency
Authorization for the acquisition of Controlled Drugs (AMC)
Market Authorization (MIA) for Drugs
Preparation, review, and submission of the MIA technical dossier
National Market Authorization Procedure (MIA)
Mutual Recognition Procedure for Market Authorization (MIA)
Decentralized Market Authorization Procedure (MIA) - DCP
Centralized Market Authorization Procedure (MIA)
Conversion of MIA dossiers from NTA format to eCTD format
Post registration Services (Hosting Services - Local Representation for Drugs and APIs) - Legal Representative, Pharmacovigilance, and Technical Representation
Import and export of Drugs and APIs
Market Access Strategies
Authorization to conduct Clinical Trials for Drugs
Scientific, regulatory and technical writing
Good Manufacturing Practice Certification for Drugs
Good Manufacturing Practice Certification for Active Pharmaceutical Ingredients
Good Distribution and Storage Practice Certification for Drugs
Good Distribution and Storage Practice Certification for Active Pharmaceutical Ingredients
Services for Chemistry, Manufacturing and Controls (CMC)
Request authorization for compassionate use, expanded access and post-study drug supply
Establish specific treatment indications
Cancellation of Active Pharmaceutical Ingredient Registration
Adverse Drug Reaction (ADR) Notification
Transfer of Active Pharmaceutical Ingredient Registration Ownership
Periodic Safety Report (PSR) - PSUR
Transfer of Medicinal Product Registration Ownership
Health Economics and Outcomes Research (HEOR) Assessment
Risk Classification Analysis - Determining the correct classification of drugs according to the local regulatory authority
Preparation of regulatory advices
Clarification of safety and efficacy beneficial claims for patients and physicians
Registration Renewal
Toxicological services and risk assessment
Post-registration Changes
Training
Equivalence Assessment
Description of dosage, frequency and route of administration
Regulatory-strategic support
Clarification of technical doubts
Documentation Gap Analysis
Feasibility report preparation for Drugs and APIs regularization
Regulatory Impact Assessment
Pharmacovigilance for Clinical Trials
Issuance of health licenses/authorizations
Pharmacovigilance
Qualified Person (QP) Services
Batch Release
Periodic benefit-risk assessment report
Reporting reactivation of Medicine manufacturing/importation
other services
Regulatory & Quality
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Distribution Headhunting
ELS Solutions is a certified company in Europe and Latin America, with strong technical and strategic knowledge in Regulation and Quality Assurance.
Import
ELS Solutions provides a robust Import, Warehousing, Billing and Customer Service service, in the countries where it is represented, so that the customer controls their business, their margin and does not need to depend on the distributor, focusing on increasing of sales.
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