Regulatory Submissions Expertise

BioTechLogic has experience in the preparation of regulatory submissions documentation.

Our team’s expertise in genetics, cell banking, protein, blood products and oligonucleotide technology, drug substance and drug product development and manufacturing, facilities and BioAnalytical methodology provides the essential core knowledge needed to prepare a complete, harmonized CMC submission.

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BioTechLogic has experience in the preparation of the following regulatory submissions documentation…

Investigation New Drug Applications (INDs)
Investigational Medicinal Product Dossier (IMPDs)
New Drug Applications (NDAs) and Abbreviation New Drug Applications (ANDAs)
Biologic License Applications (BLAs)
Marketing Authorization Applications (MAAs)
Biosimilar 351 (K) BLA
Briefing Packages
FDA and EMA Responses to Regulatory Agency Questions and Inquiries

BioTechLogic’s team has prepared Chemistry, Manufacturing, and Controls (CMC) documentation as well as Quality Overall Summaries (QOS) in the CTD Format that have been submitted globally. We have a complete and experienced team to prepare Module 2 (QOS) and Module 3 (Quality) of the CTD.

Our team’s expertise in genetics, cell banking, protein, blood products and oligonucleotide technology, drug substance and drug product development and manufacturing, facilities and BioAnalytical methodology provides the essential core knowledge needed to prepare a complete, harmonized CMC submission.

Examples of regulatory submissions projects:

COMPOUND	REGULATORY EXPERIENCE
Recombinant Protein(s) – PEGylated Growth Hormone Antagonist; Recombinant Proteins; and Recombinant MIP-1α Derivative	NDA, MAA, ROW: Module 3 (Quality) – DS and DP CMC BLA: DS/DP Analytical Sections of eCTD IND: All Modules of eCTD (Entire Submission: Administrative Information and Prescribing Information,QOS,Clinical and Non‐Clinical) Commercialization Readiness/Submission Gap Assessment Briefing Package: CMC Responses: FDA, EMA and Brazil – CMC Submission Project Management
Vaccines – Adjuvanted Therapeutic	BLA, MAA: Module 2 (QOS) and Module 3 (Quality) – Adjuvant, DS and DP CMC Briefing Package: FDA – CMC Responses: FDA and EMA – CMC Commercialization/Submission Plan Regulatory/Technical Review of Source Documents Expert Review of Regulatory Submission
Antibodies – PEGylated Antibody Fragment, Monoclonal Antibody	Briefing Package: Pre-BLA IND, IMPD, BLA, MAA: Module 3 (Quality) – DS and DP CMC PAS: Module 3 (Quality) – DP CMC ROW: CMC Submission Project Management Responses: FDA and EMA – CMC Briefing Package
Biosimilar – Recombinant	MAA: Module 2 (QOS) and Module 3 (Quality) – DS and DP CMC EMA Responses
Fusion Protein(s)	MAA, BLA: Module 3 (Quality) – DS and DP CMC and Device PAS: Module 3 (Quality) – DS and DP CMC Combination Product Regulatory Strategy Device Design Control Summary
Blood Products	Briefing Package: Facility BLA: Module 2 (QOS) and Module 3 (Quality) – DS and DP CMC
Combination Products – Drug and Device Combination, Novel Therapeutic, Recombinant	Mock FDA PAI Audit, Internal Audit, Facility addition assessment NDA: Amendment MAA/BLA: Module 3 (Quality) – DS and DP CMC and Device Pre-Filled Syringe Design Control Summary Combination Product Regulatory Strategy Device Design Control Summary FDA Responses to address gaps in Combination Product (Pre-Filled syringes)
Oligonucleotides – Oligonucleotide, RNA, DNA Aptamer	NDA, MAA: Module 3 (Quality) – DS CMC IND: Module 3 (Quality) – DS and DP CMC
Small Molecule – Gel Capsule, Parenteral (Controlled Substance)	FDA Responses ANDA: CMC

Regulatory Submissions Expertise

BioTechLogic has experience in the preparation of regulatory submissions documentation.

Examples of regulatory submissions projects:

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