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Regulatory Affairs and Quality Assurance

• Thorough understanding of Health Canada, US FDA, European Union, Australia, Japan and other international drug agency regulations, guidelines, filing requirements and approval process

• Prepare Natural Health Products (NHPs) and Medical Device licensing application as per regulatory requirements

• Expert in writing and reviewing - SOPs, user guides for medical devices as well as chemical instrumentation training material

• Prepare and review and translate Clinical Trial Application (CTA), clinical trial labels, clinical trial protocols, Informed Consent Forms, patient information, Site Visit report, Adverse Events

• Review pharmaceutical / drug promotional material as per regulatory legislations

• Communicate with regulatory agencies regarding Clarifax response, pre-NDS meeting, Pharmaceutical Advertising Advisory Board (PAAB)

• Hands-on experience to prepare product labeling, product description & packaging, package inserts, product monograph, summary of product characteristics (SPC) according to regulatory requirements

• Hands-on experience to prepare regulatory submissions: CTA, NDS, ANDS, SNDS, DMF, DIN and EL submissions in CTD format

• Gather, prepare, and review of Chemistry and Manufacturing CMC information

• Assess, coordinate and compile deficiency responses, post-approval changes, Notifiable Changes

• Technical knowledge of quality assurance, GMP, ISO, ICH Guidelines

• Expert in translation from Hindi, Marathi, French, German, Spanish into English

Skills & Expertise

Chemical InstrumentationChemistryEnglish LanguageFrench LanguageGerman LanguageHealthHindiInternationalLicensingMedicalNatural Health ProductsQuality Assurance (QA)SpanishTax FilingTrainingTraining Material WritingTranslationUser GuidesWriting

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