CMC, Quality, and Regulatory

Guidance to ensure safety and compliance

We are your strategic partners for CMC

Our experienced CMC Advisors and Consultants help you establish a robust clinical process to support your candidate through different phases of clinical development.  Our experts assess, establish and improve functions like process development, analytical development, manufacturing, quality control, quality assurance and supply chain to meet operational and regulatory needs of your candidate.  

We are partnered with some of the largest and most reliable CROs and CDMOs in the industry, saving you time and money. We help design studies and generate Module 3 content for your regulatory submissions with support from our partners.

Customizable CMC and Regulatory Advisory and Consulting to support all stages of your company’s lifecycle

Consulting and Advisory Menu

    • Establish clinical process

    • Assessment of raw materials, consumables, excipients and primary packaging

    • Assessment of technology

    • Formulation development

    • Scale down studies

    • Surrogate molecular/biological entity evaluations

    • IND enabling PD studies

    • IND submission module 3 content

    • Technology transfer

    • Technology assessment including rapid technologies

    • Method development

    • Custom reagent design

    • Method qualifications, verifications and validations

    • Stability studies

    • Compatibility studies

    • Specification development

    • IND submission module 3 content

    • QC methods transfer

    • Establish GXP Quality System

    • Supplier audits and risk-based qualifications

    • Quality agreements

    • GMP training

    • Label generation

    • Risk assessments

    • Change management

    • Continuous improvement

    • Investigation

    • Product release

    • Support competent authority inspections

    • Assess contract testing labs

    • QC lab establishment

    • Methods and equipment SOP including safety tests

    • Environmental monitoring

    • Technology transfer

    • Domestic and international CDMO capability assessments

    • Sterile assurance and facility assessments

    • Utilization cost models

    • Aseptic process simulation approaches

    • Technology transfer

    • Batch record review

    • Person in plant

    • Investigation support

    • Process validation : CPP assessments

    • Supplier assessments

    • RFP generation and contract negotiation

    • Master services agreement

    • Shipping Qualifications

    • Inventory management

    • Bill of materials

    • Investigational product import/export

    • Briefing book

    • Pre-IND interactions

    • IND consulting and drafting

    • Annual updates

    • BLA and NDA consulting

    • aBLA and ANDA consulting

“Ipsita’s calm style and strong mentorship capabilities have made a huge impact on the internal and external cross-functional teams delivering clinical trial materials. The teams appreciate her candid, timely and valuable feedback for improving business processes. Her ability to see the big picture, identify gaps and prioritize patients and sponsor needs speaks to her multifaceted drug development and compliance expertise.” Robert Towarnicki, CEO, SIRPant Immunotherapeutics

“Ipsita’s calm style and strong mentorship capabilities have made a huge impact on the internal and external cross-functional teams delivering clinical trial materials. The teams appreciate her candid, timely and valuable feedback for improving business processes. Her ability to see the big picture, identify gaps and prioritize patients and sponsor needs speaks to her multifaceted drug development and compliance expertise.” Robert Towarnicki, CEO, SIRPant Immunotherapeutics

This is long overdue. Y Innovations really has some of the best experts in crisis management - very discrete. If you need a fixer, especially if there is a government agency involved, contact them.” Confidential

This is long overdue. Y Innovations really has some of the best experts in crisis management - very discrete. If you need a fixer, especially if there is a government agency involved, contact them.” Confidential