Regulatory affairs

Bringing a new product from laboratory development to marketing approval is a lengthy and very expensive process. If any delays occur because of the regulatory issues could seriously cost the innovator money and time.

Katalyst HealthCares & Life Sciences is providing seamless, transparent, and current good regulatory consulting services to clients across Pharmaceutical, Biotechnology, API manufacture, Finished Formulations Manufacture, Medical Device, Food, and Beverage companies.

Our services range from a simple advisory service consulting to full IND, NDA, and IDE preparation and submission, including submissions in electronic Common Technical Document (eCTD) format using cGxP systems.

Highly experienced and broad knowledge Katalyst’s team members, including Clinical, Medical Safety, Data Management, Statistics and Project Management, are available to assist as single or as a completely manageable fully functional clinical development team to ensure successful product registration in American, European and all other global markets.

Katalyst HLS offers wide range of Regulatory Services

  • Regulatory affairs: CMC, Dossiers

  • Regulatory Strategy and Intelligence from Molecule to Market.

  • Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD)

  • Regulatory Writing: Clinical and CMC

  • Regulatory support for Clinical Trials

  • Regulatory Operations: Clinical and Non-Clinical Publishing and Submission.

  • Regulatory Labelling: Clinical and Non-Clinical

  • Regulatory Agency Liaising

  • Regulatory Business and Outsourcing Consultanc

Regulatory affairs

Intellectual property protection is essential for safeguarding innovation and maintaining competitive advantage in the life sciences industry. Effective IP management supports informed decision-making, portfolio optimization, and long-term value creation across global markets.

Katalyst HealthCares & Life Sciences Own Intellectual Property (IP) department serves the intellectual needs of Pharma, Biotech, and Medical Device companies in the very competitive life sciences field. In Cooperation with our international network of patent attorneys and lawyers specializing in the field of Healthcare and Life Sciences, we offer diverse services related to Active Pharmaceutical Ingredients (API), Pharmaceutical and Biotech drug products in generic and new discovery research, Medical Devices.
US, EU, JP & ROW Markets.

Patent Search Services

  • Search & Analysis of Patents

  • Identifying design around strategies

  • Patentability study

  • Invalidity study

  • Search Reports

  • Providing the clearances

Patent Filing Services

  • Patent Drafting

  • Filing Patent Applications

  • Filing PCT Applications

  • Formulating the Strategy and Filing Patent Applications in different Countries Through Professional Partners

  • Prosecution / Examination Services

  • Preparing and Filing Oppositions

  • Maintenance of patents

  • Opinions on Orange Book / Patent Register patents

  • ANDA Certifications for US, CA.

  • Notice Letter

Portfolio and Innovation Management Services

  • Active Pharmaceutical Ingredient (API)

  • Formulations/Drug Products/Dosage Forms

  • Biotechnology Products

  • Generic Product Selection

  • Finished Dose Forms

  • Medical Devices

  • Para IV / Niche Product Opportunities

  • Establishing Systems for Organizations to Manage IP

  • Project Management for Developing Products

  • IP Due Diligence

  • New indications Identification for existing products

  • New dosage forms Identification for an existing product

  • Building and Managing IP Portfolios