Therapeutic knowledge and understanding of key problems

Strategic Planning solutions that assist clients to develop new products and reduce time to market, harnessing the company’s expertise in many therapeutic areas, including oncology, autoimmune diseases, cardiovascular, CNS, dermatology, and infectious diseases.

The service includes all the key expertise and processes required to satisfy regulatory requirements and smooth the way to market approval for biologicals (including biosimilars), vaccines, small molecules, generics, and medical devices.

Our services include

  • GLOBAL REGULATORY INTELLIGENCE

    RegPak possesses the in-depth knowledge and experience in various regulatory regimes that allow it to play a leading role or agency for the preparation of the key documents required.

  • NEW PRODUCT DILIGENCE

    RegPak can undertake the conduct of due diligence required to verify proposed new products against regulatory demands.

  • NUTRITIONAL & FOOD SUPPLEMENT

    We provide comprehensive scientific, technical, regulatory, legal, and project management services Nutraceuticals are food or food ingredients that have defined physiological effects.

  • COSMETICS

    Cosmetic products are topical products that are not classified as medicinal products. Cosmetic products are also important consumer products: apart from “traditional” cosmetic products, such as make-up and perfumes, it also includes products for personal hygiene, for example, tooth-care products, shampoos, and soaps.

  • QUALITY ASSURANCE AND REGULATORY INSPECTIONS

    RegPak can provide assistance in preparing for and managing GxP audits or inspections.