Regulatory Service
Entry to the vast realm of pharmaceutical products in international markets requires a detailed understanding of complicated regulatory requirements. At ACOMA INTERNATIONAL, our Drug Regulatory Affairs (DRA) consultants assist companies to plan and manage their pharmaceutical and medical product development programs and regulatory requirements. We ease the process of getting swift approval for your products by defining country specific regulatory strategies right at the nascent stage of product development and eliminating potential roadblocks en-route to a successful product launch.
Our Regulatory Services include:
Registration Service:
- DMF (CTD format) Preparation, Review and Submission
- Dossier Writing and Review
- Dossier Registration
- COA, COPP
- Notarization
Post-Approval Changes:
- Product re-registration and
- Renewal of site according to schedule
- Post-approval lifecycle maintenance
- Report compilation and publishing
Pre-Registration Service:
- Drug Product DMF
- Development & Preparation of documents
- Content creation and document service
Research & Development
This department is the backbone and also the life force of the company. It is here with an aim to bring our vision and mission to life. Our R & D division focuses on development of new products and drug across a wide range of therapies including Tablets, Capsules, Injection, Cream, Dry Syrups. Research and Development team is headed by experienced scientists, chemists and technicians with proficient knowledge in pharmaceutical industry.
Our Dosage Development Laboratory is equipped with following capabilities:
- Development of novel, modified release Solid Oral dosage forms
- Cost effective Test masking Technology
- Development of drugs with poor solubility to enhance solubility and bioavailability
- Design and development of pharmaceutical products of International standards.
- Pre-formulation studies.
- Lab / pilot scale development and stability studies.
- Scale up for process optimization / validation.
- Technology transfer of new products.
- Technical assistance for manufacturing.
- Data management (for transfer to customer / Regulatory Affairs).
- Prototype Equipment’s as that of manufacturing facilities.
