Main Line: +1 (919) 637-7105
Greater Philadelphia Area, Pennsylvania - USA

Consulting Services

Chemical Manufacturing & Controls (CMC) Development

The CMC is an integral part of the entire drug development program with major influences from and to clinical studies and regulatory requirements. Our CMC consulting services help deliver the best possible clinical-grade products by navigating through the aspects of regulatory & compliance.

At TechnoPharmaSphere we provide all-inclusive CMC consulting services for biopharma product development. TechnoPharmaSphere brings you a full span of expertise in CMC technical, regulatory, project management, manufacturing, and GMP compliance. We also provide sample testing and wet work services.

We have direct industry experience in all the dimensions of CMC development. We provide consulting services starting right from discovery and pre-clinical development to drug product formulation for clinical and commercial manufacturing.We offer a broad spectrum  of consultation services for protein-based, peptide, small molecules, exosome, DNA, RNA,  cells, and gene therapy products

Our involvement from the onset helps you save substantial time and money in the product development processes. From discovery and research to development and manufacturing, we provide you with various consultation services to ensure full work packages that are suitable for successful regulatory submissions.

Project Management

  • Entire or partial CMC strategy and management
  • CMC interface with regulatory & clinical development
  • Collaboration with technical teams on executing CMC work packages
  • Final protocols and reports
  • Supply chain management in USA, EU and MENA

Manufacturing

  • Quality by Design (QBD)
  • PQ batches
  • Manufacturing and release of clinical batches
  • Final protocols and reports
  • Technical writing for regulatory documents

Discovery and Early Research

  • Candidates screening
  • Developability work packages
  • Candidate selection (CS)
  • Early research work packages preparing for CS
  • Final protocols, reports, and CS document
  • Technical writing for regulatory documents

Drug Product

  • Pre-Formulation/Formulation development
  • Delivery systems and devices
  • Formulation optimization
  • Process tech transfer to manufacturing
  • Final protocols and reports
  • Technical writing for regulatory documents

Analytical & Biophysical Methods

  • Method Development
  • Raw data analysis and results interpretation
  • Forced degradation studies
  • Qualification & validation
  • Tech transfer and implementation at QC and manufacturing
  • Incident investigation
  • Final protocols and reports
  • Technical writing for regulatory documents

Product’s Quality

  • Specifications
  • Structure-function relationships (in vivo & in vitro)
  • Forced degradation studies
  • Product’s Critical Quality Attributes (CQAs)
  • Characterization and comparability
  • Final reports and protocols
  • Technical writing for regulatory documents

Stability Studies

  • In-process and intermediates
  • Development stability studies for DS and DP
  • Final GMP stability for DS & DP
  • Incident investigation
  • Shelf-life stability and expiry date estimation
  • Final reports and protocols
  • Technical writing for regulatory documents

Process Development

  • Cell culture and purification development
  • Tech transfer to manufacturing
  • Process control strategy
  • Raw material selection and characterization
  • Evaluation of process impurities
  • Final protocols and reports
  • Technical writing for regulatory documents

Contract Organization

  • CRO/CDMO/CMO evaluation & management
  • Preparing strategy and study design
  • Auditing for required level of compliance
  • Study monitoring, including onsite observations and raw data review
  • Detailed review of draft report and conclusions
  • Study report finalization
  • Project management

Positron Emission Tomography (PET)

  • Label the product with radio active material
  • Manage testing products, product specs, development and QC tests
  • Manage the entire CMC milestones of methods, formulation and manufacturing process in R&D and GMP suites.
  • Interface with regulatory and clinical teams
  • Supply chain for clinical trials
  • Compile CMC sections in regulatory submission
  • Evaluate and audit CRO/CMO for CMC development and clinical material manufacturing and testing
  • Manage CMC and clinical sites to ensure smooth and timely clinical trials