Solvekta is mainly engaged in the development of oral, oro-mucosal and topical pharmaceuticals for specialty pharma (505b2); generics (ANDA) as well as consumer/OTC companies. A team comprised of all scientific disciplines for finished product CMC is available to lead product development from bench top to process validation.
We enable discovery and drug delivery startups with formulation & process development, pre-formulation, analytical development, validation, technology transfer, project management and regulatory filings.
Solvekta Consulting provides a customer-focused pharmaceutical consultancy offering technical guidance for product development, training, critical process reviews, audits and project management. With 30 years’ experience in the pharmaceutical industry, we cover a variety of types of projects from generic portfolio development and registration to complex drug delivery approaches and regulatory strategies as well as new chemical entity development to clinical phase. Our services are tailored to your requirements.
Solid oral dosage forms
Solvekta Consulting can offer a wide range of support for dosage forms, from candidate selection through to NDA submissions, both for new chemical entities and product line extensions of a number of oral dosage formulations:
- Tablets (IR, MR, ODT, Bilayer FDC, matrix and multiparticulate dosage forms)
- Capsules – hard capsules and softgels
- Thin films – orally disintegrating, buccal and sublingual.
- Oral solutions and suspensions
Topical dosage forms
Solvekta Consulting also offers support for topical product development of various types such as creams, lotions, gels, oils and patches.
Pharmaceutical regulatory and management services
Having hosted FDA meetings and pre-approval inspections, we have many years of experience leading trans-national teams based in Europe, India and the United States of America for development of products for worldwide commercial markets.