Archives: FAQs

FDA Meetings

Type AType B / Type B (EOP)Type DINTERACT and INTERACT “lite”Formal and informal meetings with OOPDPre-Sub (Q-sub)ANDA product development and pre-submissionInformal meetings

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Regulatory Assets

Breakthrough Designation Fast Track Designation Orphan Designation Rare Diseases Voucher Special Protocol Assessment Tropical Diseases Voucher Small Business Designation

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Dosage Form Experience

CapsulesCreamsGelsLiposomesMedical GasesMicrodose PowdersMonoclonal AntibodiesParenterals (liquid lyophilized)Parenterals (powder fill)OverencapsulationPatchesPowdersSynthetic and Semi-synthetic Drug SubstancesTablets (IR and E...

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Therapeutic Area Experience

AllergyCardiovascular/RenalDermatologyDiagnostic and Therapeutic RadiopharmaceuticalsGIImmunologyInfectious DiseaseNeurologyOncologyOphthalmologyPainPsychedelicsPsychiatryReproductive HealthUltra Rare Diseases

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Application Type Experience

505(b)(1) 505(b)(2) 505(j) – ANDA Medical Device Combination Products IND IDE DMF Orphan Breakthrough Rare Pediatric Disease Rare Tropical Disease Small Business

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