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CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

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.

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 InformationQOSClinical 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