END-TO-END REGULATORY SERVICES THROUGHOUT THE ENTIRE MEDICINE LIFE CYCLE
Our associated experts are scientists who have extensive backgrounds and experiences in global regulatory affairs and pharmaceutical development so that our solutions may cover exactly the capabilities you need.
Preparation/submission of marketing authorization applications – National registration, MRP, DCP, CP registration.
Innovative and generic medicinal products including biotech – Medical devices – Illicit drugs (Cannabis) – Herbal medicinal products – Radiopharmaceuticals – Food supplements – Cosmetics – Biocides – Vaccines – Homeopathic medicinal products.
Expert report: pre-approval/post-approval and submission support – various applications, renewals, and notifications – update and upgrade of documentation – SPC, PIL, labelling – marketing materials review, harmonization with approved medicinal products documents – communication with authorities (new requirements/answers to deficiency/ clarifications/permissions) – packaging materials (mock-ups/artworks) and proofreading.
Our concept is to collaborate with reputable regulatory affairs service providers in other countries of EU on a contract basis. It is our objective to establish an integrated EU network of independent regulatory experts to secure the complex international solution for our partner by:
- Complementary services
- Additional resources
- Coverage of the countries in EU
Our efforts contribute to better understanding of local regulatory requirements to every project. By staying ahead of all current legislation, guidelines, and other regulatory intelligence, it would enhance the delivery of localised services to our partners.
Our consultants provide Quality System (QS) and regulatory services to the partners pertaining to GMP standard with the objective to obtain the proper certification.
- Due diligence process
- Establishment of Quality System (QS): preparation/ review of Quality Manual, Standard operating procedures (SOP), Working instructions
- Trainings of personnel
- Quality review process (QC/QA)
- Risk minimisation system
- Performance of pre-inspection
- Setting up appropriate contractual arrangements and supervision