CMC & Product Development

One team owns the molecule from bench to commercial launch. Every design decision starts with the clinical need (QTPP) and the patient, and carries the P&L and the regulatory pathway in view from the first batch.

Formulation development

Oral solids, modified and controlled release

Oral disintegrating tablets (ODTs), buccal and sub-lingual tablets

Liquid orals: solutions and suspensions

Simple to complex injectables and sterile products

Nasal, ophthalmic and inhalation (DPI and nasal delivery)

Pediatric dosage forms: liquids, taste-masked ODTs, mini-tablets

Specialised technical capability

HPAPI development and setting up high-potent facilities

Bioavailability enhancement for poorly soluble molecules

API selection, preformulation and polymorph screening

QbD-driven formulation development

Stability strategy and lifecycle management

Scale-up and supply

Process development, scale-up and tech-transfer

Quality by Design (QbD) based product development

Process validation and commercial launch

CMC documentation for regulatory submissions

Manufacturing and supply-chain risk assessments

Have a program that needs CMC and product development? Tell us where it stands.

Request a consultation

All services →

Credence

Pharma

Credible partners for pharmaceutical & life-sciences clients. Evidence-led advisory in CMC, regulatory, quality and strategy for NCEs, generics and branded-generics.

Firm

Services Approach Who we are Mission & values The Team Case studies Careers Contact

Contact

inquiry@credencepharma.com bd@credencepharma.com HR@credencepharma.com +1 416 508 2061

Mississauga, Ontario, Canada

Privacy Terms credencepharma.com