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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

General Toxicology
Reproductive Toxicology
Safety Pharmacology
Isotope Chemistry & Drug Disposition
Bioanalytical Services
General Toxicology
Reproductive Toxicology
Safety Pharmacology
Isotope Chemistry & Drug Disposition
Bioanalytical Services

 Need information?

Please contact us if you would like to arrange a visit to your company by one of our representatives, to request a proposal, or for any more information on our services.

info@accelera.org

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