CMC Consulting for OTC/Nutraceuticals, specialty pharmaceuticals and drug delivery
Solvekta is a consulting company incorporated in North Carolina, US. We provide CMC consulting services for the healthcare industry and assist companies in product development and regulatory filings for marketing approval.
We are committed to enabling healthcare companies in developing and marketing products to improve human health and wellness.
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Solvekta is engaged in the development of oral, oro-mucosal, and topical pharmaceuticals for specialty pharma (505b2), generic (ANDA), and 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 and 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 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 support for a wide range of 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 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 for development of products for worldwide commercial markets.
Solvekta assists specialty nutraceutical companies in the development of novel film and gel based nutraceutical dosage forms tailored for the US market.
Please contact us for further information on our products and business areas.
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