Regulatory Services
Accelera’s regulatory consulting team can help you keep track of the ever-changing regulations in various regions of the world, develop a regulatory strategy for your product’s lifecycle, help interface with the relevant regulatory agencies, and assist in the preparation of required registration documents.
In Vivo (ICH compliant – GLP regulated)
Accelera also offers a full regulated in vivo toxicological package, with studies conducted via different routes of administration, including TK evaluation in adult animals and pups:
Investigational New Drug (IND) preparation
Preparation of documents for pre-IND and Scientific Advice meetings with Regulatory Authorities
Investigator Brochure (IB) preparation
Investigational Medicinal Product Dossier (IMPD) preparation
Common Technical Document (CTD) preparation
Review of Sponsor-prepared documents
Due diligence, gap analysis
Safety Assessments/Expert Reports
Orphan Drug Application
Calculation of the Permitted Daily Exposure and preparation of the “PDE determination strategy” document
Other Services
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