Regulatory Services

Regulations related to Pharmaceutical products in Philippines continue to pose a major challenge for the global generic industry. In such situation – a sound regulatory strategy is key to get the products registered and opens ways for new business alliances.

Any sound regulatory strategy stands on effective planning and implementation. Regulatory Operations by way of New Filings, dossier compilations or variations, running procedures on client’s behalf is an influential support for startups and established businesses as well.

Ambica provides regulatory services required throughout the product life cycle i.e. from Production to Launch to Post Launch activities.

Ambica helps pharmaceutical companies to manage their regulatory affairs assignments by dossier compilation, regulatory filings & approvals, post approval renewal management, regulatory compliance and regulatory support for marketed products.

Core Regulatory Services we offer:

• Registration of Drug Products, Medical Devices, Food Products and Supplements, Cosmetics Preparations, Herbal Medicine, Veterinary Drug Products, House hold and Hazardous substances.
• Post Approval Registration Management: Renewals, Variation & Clinical Trials Assistance – according to ACTD & CTD Harmonized guidelines.
  • Dossier compilation – Regional, CTD & ACTD formats.
  • Protocol writing – Clinical & Post Marketing Surveillance.
  • Trade mark registration – as per Philippines IPO regulations.